Clip, Vascular
The Vascular Clip is a small implantable cardiovascular device used to occlude, ligate, or temporarily clamp blood vessels during surgical procedures, permanently or temporarily interrupting blood flow in a controlled manner. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSS and it is regulated under 21 CFR 870.3250 within the Cardiovascular medical specialty. This device is flagged as an implant.
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Basic Information
- Product Code
- DSS
- Device Class
- FDA class 2
- Regulation Number
- 870.3250
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K983744 | MCAS (MODULAR CLIP APPLIER SYSTEM) | Jan 21, 1999 | Substantially Equivalent | Applied Medical Resources |
| K961333 | HEARTPORT MULTIFIRE CLIP APPLIER | Nov 15, 1996 | Substantially Equivalent | Heartport, Inc. |
| K920104 | IDENTI LOOPS DEGANIA SILICONE | Apr 20, 1992 | Substantially Equivalent | Puritas Health Care, Inc. |
| K920676 | RMI SOFCLAMP | Apr 15, 1992 | Substantially Equivalent | Research Medical, Inc. |
| K914523 | CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL | Jan 10, 1992 | Substantially Equivalent | Catheter Research C/O Burditt, Bowles & Radzius |
| K901303 | HORIZON SURGICAL LIGATING AND MARKING CLIP | Jun 05, 1990 | Substantially Equivalent | Horizon Surgical, Inc. |
| K883909 | SURGICAL SPRING CLIPS | Dec 27, 1988 | Substantially Equivalent | Applied Vascular Devices, Inc. |
| K771021 | AUTO-CLIP | Jun 14, 1977 | Substantially Equivalent | Axiom Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.