DSS · Clip, Vascular
Cardiovascular · 21 CFR 870.3250 · Class 2
Overview
| Product Code | DSS |
|---|---|
| Device Name | Clip, Vascular |
| Regulation | 21 CFR 870.3250 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A vascular clip is an implanted extravascular device designed to occlude, by compression, blood flow in small blood vessels other than intracranial vessels.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K983744 | MCAS (MODULAR CLIP APPLIER SYSTEM) | Applied Medical Resources | Jan 21, 1999 | SESE |
| K961333 | HEARTPORT MULTIFIRE CLIP APPLIER | Heartport, Inc. | Nov 15, 1996 | SESE |
| K920104 | IDENTI LOOPS DEGANIA SILICONE | Puritas Health Care, Inc. | Apr 20, 1992 | SESE |
| K920676 | RMI SOFCLAMP | Research Medical, Inc. | Apr 15, 1992 | SESE |
| K914523 | CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL | Catheter Research C/O Burditt, Bowles & Radzius | Jan 10, 1992 | SESE |
| K901303 | HORIZON SURGICAL LIGATING AND MARKING CLIP | Horizon Surgical, Inc. | Jun 5, 1990 | SESE |
| K883909 | SURGICAL SPRING CLIPS | Applied Vascular Devices, Inc. | Dec 27, 1988 | SESE |
| K771021 | AUTO-CLIP | Axiom Medical, Inc. | Jun 14, 1977 | SESE |
Top Applicants
- Applied Medical Resources — 1 clearance
- Applied Vascular Devices, Inc. — 1 clearance
- Axiom Medical, Inc. — 1 clearance
- Catheter Research C/O Burditt, Bowles & Radzius — 1 clearance
- Heartport, Inc. — 1 clearance
