IntraCoil Self-Expanding Peripheral Stent

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K021563 ↗

FDA Product Code

JCT

Device Class

Class II

Regulation

21 CFR Part 878.3720

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

  Class II

  FDA 510(k) K012347 Active Cleared 23 Aug 2001

• Modification to Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

  Class II

  FDA 510(k) K021729 Active Cleared 21 Jun 2002

• Intrastent Ld (Large Diameter) Stent

  Class II

  FDA 510(k) K020528 Active Cleared 16 Apr 2002

• Protege Self-expanding Nitinol Stent With Starport Delivery Technology

  Class II

  FDA 510(k) K011806 Active Cleared 7 Sep 2001

• Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

  Class II

  FDA 510(k) K012066 Active Cleared 1 Aug 2001

• Modification to Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

  Class II

  FDA 510(k) K023243 Active Cleared 13 Dec 2002

See all devices from Sulzer Intratherapeutics, Inc. →

• What types of peripheral arteries is the IntraCoil Self-Expanding Peripheral Stent designed to treat, and how is it deployed in clinical practice?

  The IntraCoil Self-Expanding Peripheral Stent is specifically designed for use in peripheral arteries, including the femoropopliteal region and tibial bifurcation areas, to treat stenotic or occlusive atherosclerotic lesions. It is supplied premounted on a delivery catheter, allowing physicians to deploy it directly in clinical settings during procedures. The stent’s self-expanding mechanism ensures it can be placed precisely within the target vessel.

• Is the IntraCoil Stent reusable for multiple deployments, and what limitations should clinicians be aware of regarding its use?

  Yes, the IntraCoil Self-Expanding Peripheral Stent is reusable for multiple deployments, which can help reduce waste and costs. However, clinicians should note that it is not intended for MRI use, meaning it should not be placed in patients who require MRI imaging. Additionally, its use is limited to peripheral arteries, and deployment must be performed in clinical settings using the provided delivery catheter.

• What sizes and reference vessel diameters are available for the IntraCoil Stent, and where can this information be found?

  The available sizes and reference vessel diameters for the IntraCoil Self-Expanding Peripheral Stent are specified in the manufacturer’s product catalog. Since the device is designed for various peripheral arteries, clinicians should consult the catalog to select the appropriate size for their patient’s vessel diameter. The catalog ensures compatibility with the target anatomy for optimal placement and performance.

• How is the regulatory status of the IntraCoil Stent determined, and what does the 510(k) clearance indicate?

  The IntraCoil Self-Expanding Peripheral Stent holds an FDA 510(k) clearance (K021563) under the Special Review pathway, classified as a Class II medical device (product code JCT). This clearance indicates that the FDA has determined the device is substantially equivalent to a legally marketed predicate device, meaning it meets the same performance standards and safety requirements. The clearance does not imply an indication for use but confirms regulatory compliance for marketing and distribution in the U.S.