CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL
FDA 510(k) clearance K914523 · decided 1992-01-10
Clearance details
- K-number
- K914523
- Device name
- CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL
- Applicant
- Catheter Research C/O Burditt, Bowles & Radzius
- Decision
- Substantially Equivalent
- Date received
- 1991-10-10
- Decision date
- 1992-01-10
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- DSS
- Device class
- 2
- Regulation number
- 870.3250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.