GELSOFT PLUS ERS
FDA 510(k) clearance K034010 · decided 2004-02-19
Clearance details
- K-number
- K034010
- Device name
- GELSOFT PLUS ERS
- Applicant
- Vascutek, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-24
- Decision date
- 2004-02-19
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |
| 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 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
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| HeRO Graft (K213845) | Merit Medical Systems, Inc. | 2022-08-15 |
| exGraft, exGraft Carbon (K221628) | Peca Labs | 2022-08-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Thoraflex Hybrid (P210006/S015) | Vascutek, Ltd. | 2025-10-29 |
| Thoraflex Hybrid (P210006/S014) | Vascutek, Ltd. | 2025-10-16 |
| Thoraflex Hybrid (P210006/S013) | Vascutek, Ltd. | 2025-07-30 |
| Thoraflex Hybrid (P210006/S012) | Vascutek, Ltd. | 2025-04-09 |
| Thoraflex Hybrid (P210006/S010) | Vascutek, Ltd. | 2025-03-28 |
| Thoraflex Hybrid (P210006/S011) | Vascutek, Ltd. | 2025-01-27 |
| Thoraflex Hybrid (P210006/S009) | Vascutek, Ltd. | 2024-08-01 |
| Thoraflex Hybrid (P210006/S007) | Vascutek, Ltd. | 2024-01-11 |