DSS
8 FDA 510(k) clearances · Product code
92 daysmedian time to decision
221 days90th percentile
8clearances measured
FDA profile
- Official device name
- Clip, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3250
- Medical specialty
- Cardiovascular
- Flags
- Implant
- Adverse events (MAUDE)
- 2004: 3 · 2005: 3 · 2007: 5 · 2008: 2 · 2012: 5 · 2020: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MCAS (MODULAR CLIP APPLIER SYSTEM) (K983744) | Applied Medical Resources | 1999-01-21 |
| HEARTPORT MULTIFIRE CLIP APPLIER (K961333) | Heartport, Inc. | 1996-11-15 |
| IDENTI LOOPS DEGANIA SILICONE (K920104) | Puritas Health Care, Inc. | 1992-04-20 |
| RMI SOFCLAMP (K920676) | Research Medical, Inc. | 1992-04-15 |
| CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL (K914523) | Catheter Research C/O Burditt, Bowles & Radzius | 1992-01-10 |
| HORIZON SURGICAL LIGATING AND MARKING CLIP (K901303) | Horizon Surgical, Inc. | 1990-06-05 |
| SURGICAL SPRING CLIPS (K883909) | Applied Vascular Devices, Inc. | 1988-12-27 |
| AUTO-CLIP (K771021) | Axiom Medical, Inc. | 1977-06-14 |
Track DSS automatically
Every clearance here is in the API, with alerts when new ones post.