Profile: InSitu Technologies Inc. is a privately held medical device company specializing in intra-vascular stents and cardiovascular products. Our products include cardiovascular stents, peripheral stents, renal stents and balloons. Our direct stent® is the solution for emergency situations like ruptures, dissections, and aneurysms. Our Monarch™ paclitaxel eluting stent is superior and dependable stent combining a biostable polymer with a proven drug and a reliable stent platform to create a powerful combination. Our Diamondback™ III is a balloon expanable stainless steel alloy stent, premounted on a over the wire button catheter and flexible open cell design. Our Arriva +™ Total Occlusion Balloon is a soft atraumatic molded tip, increased trackability and pushability. Our Raptor™ consists of hydrophilic coating. It improves catheter interface and its access to challenging anatomy. Our Radial™ is a complete line of interventional and diagnostic guidewires made with stainless steel core and teflon coating. Our Starflex™ sheath introducer kit consist of two way stop cock, arterial needle, hemostasis valve, side port, mine guidewire, color coded caps and individual sterile packs.
FDA Registration Number: 2134244
20 Products/Services (Click for related suppliers)
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• Angiography/Angioplasty Kit (FDA Code: OEQ / 870.1650) An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography. |
• Balloon Type Catheter (FDA Code: GBA / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles. |
• Catheter Cannula (FDA Code: DQR / 870.1300) A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector. |
• Coronary Covered Stent (FDA Code: NIV) |
• Coronary Drug-Eluting Stent (FDA Code: NIQ) |
• Coronary Stent (FDA Code: MAF) |
• Diagnostic Catheter |
• Diagnostic Intravascular Catheter (FDA Code: DQO / 870.1200) An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others. |
• Fiberoptic Endoscope (FDA Code: GDB / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
• Guidewire Catheter (FDA Code: DQX / 870.1330) A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. |
• Guidewires |
• Percutaneous Transluminal Coronary Angioplasty Catheter (FDA Code: LOX / 870.5100) |
• Peripheral Stent Systems |
• Peripheral Transluminal Angioplasty Catheter (FDA Code: LIT / 870.1250) A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire. |
• Puncture Needle |
• Renal Stent (FDA Code: NIN) |
• Self Expanding Peripheral Stents |
• Stent Grafts |
• Superficial Femoral Artery Stent (FDA Code: NIP) |
• Tear Away Sheath Introducer Kit |