PTFE FELTS AND PLEDGETS
FDA 510(k) clearance K041716 · decided 2004-07-22
Clearance details
- K-number
- K041716
- Device name
- PTFE FELTS AND PLEDGETS
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2004-06-24
- Decision date
- 2004-07-22
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DXZ
- Device class
- 2
- Regulation number
- 870.3470
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, 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 |
|---|---|---|
| PeriBeam® Pericardial Membrane (K240775) | Tamabio | 2025-04-18 |
| Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (K200955) | Vascutek, Ltd. | 2020-07-08 |
| PhotoFix Decellularized Bovine Pericardium (K162506) | Cryolife, Inc. | 2017-03-09 |
| VascuCel (K162579) | Admedus Regen Pty, Ltd. | 2016-10-14 |
| CorMatrix Tyke (K152127) | Cormatrix Cardiovascular, Inc. | 2016-02-04 |
| PremiPatch PTFE Pledget (K151865) | Aesculap, Inc. | 2015-10-27 |
| PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (K142447) | Synovis Life Technologies, Inc. | 2015-01-07 |
| VASCU-GUARD Peripheral Vascular Patch (K142461) | Synovis Life Technologies, Inc. | 2014-11-25 |
| CORMATRIX ECM FOR VASCULAR REPAIR (K140789) | Cormatrix Cardiovascular, Inc. | 2014-07-15 |
| CARDIOCEL (K130872) | Celxcel Pty, Ltd. | 2014-01-30 |
| SYNOVIS COLLAGEN MATRIX (TBD) (K122306) | Synovis Surgical Innovations | 2013-03-08 |
| SMI CARDIOVASCULAR PATCH (K122105) | Solinas Medical, Inc. | 2012-12-07 |
Recalls involving this device
No recalls on record reference this clearance.