SURGICAL CLAMP INSERTS
FDA 510(k) clearance K883790 · decided 1988-12-27
Clearance details
- K-number
- K883790
- Device name
- SURGICAL CLAMP INSERTS
- Applicant
- Applied Vascular Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-07
- Decision date
- 1988-12-27
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Surgical Clamp Inserts, Model#G-8600, 86MM Insert Soft/Traction, 15/Bx Surgical Clamps and recall (Z-3004-2011) | Applied Medical Resources Corp | 2011-08-11 |
| Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx Surgical Clamps and ins recall (Z-3005-2011) | Applied Medical Resources Corp | 2011-08-11 |
| Surgical Clamp Inserts, Model#G-8655, 86MM Insert Fibra/Fibra 15/Bx Surgical Clamps and in recall (Z-3006-2011) | Applied Medical Resources Corp | 2011-08-11 |