HEARTPORT CABLE BULLDOG CLAMP
FDA 510(k) clearance K962366 · decided 1996-11-07
Clearance details
- K-number
- K962366
- Device name
- HEARTPORT CABLE BULLDOG CLAMP
- Applicant
- Heartport, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-19
- Decision date
- 1996-11-07
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|
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| Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) (K253070) | Medline Industries, LP | 2025-11-20 |
| Radial Compression Device (K232577) | Ningbo Dizegens Medical Science Co.,Ltd | 2024-01-18 |
| PICOCLAMP (K230281) | Kono Seisakusho Co., Ltd. | 2023-10-23 |
| Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (K221661) | Compression Works, Inc. | 2023-03-03 |
| VIOLA (K230248) | Vascular Graft Solutions, Ltd. | 2023-02-28 |
| Radial Artery Compression Tourniquets (K222182) | Beijing Demax Medical Technology Co.,Ltd | 2023-01-04 |
| GEM Biover Microvascular Clamps (K221843) | Synovis Micro Companies Alliance, Inc. | 2022-09-14 |
Recalls involving this device
No recalls on record reference this clearance.