VASCUTEK VASCULAR PROTHESIS VP1200K/50K
FDA 510(k) clearance K830016 · decided 1983-12-21
Clearance details
- K-number
- K830016
- Device name
- VASCUTEK VASCULAR PROTHESIS VP1200K/50K
- Applicant
- Pacesetter Systems
- Decision
- Substantially Equivalent
- Date received
- 1983-01-03
- Decision date
- 1983-12-21
- Days to decision
- 352 days
- Clearance type
- Traditional
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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| exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (K233783) | Peca Labs, Inc. | 2024-01-17 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
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| HeRO Graft (K213845) | Merit Medical Systems, Inc. | 2022-08-15 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CARBON TIP CARDIAC PACING LEAD (P800041/S015) | Pacesetter Systems | 1996-01-04 |
| CARBON TIP CARDIAC PACING LEAD (P800041/S014) | Pacesetter Systems | 1994-10-17 |
| CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S011) | Pacesetter Systems | 1994-05-25 |
| CARBON TIPPED LEAD ALT.PROD.TRAYS (P800041/S012) | Pacesetter Systems | 1992-11-18 |
| CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S010) | Pacesetter Systems | 1990-12-18 |
| CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S009) | Pacesetter Systems | 1990-12-10 |
| ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S008) | Pacesetter Systems | 1989-06-19 |
| ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S007) | Pacesetter Systems | 1987-06-22 |