EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
FDA 510(k) clearance K881279 · decided 1988-05-18
Clearance details
- K-number
- K881279
- Device name
- EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1988-03-22
- Decision date
- 1988-05-18
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- DTI
- Device class
- 1
- Regulation number
- 870.3945
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Ana, CA, 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 |
|---|---|---|
| CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (K952184) | Carbomedics, Inc. | 1995-11-29 |
| VALVE SIZER (K934951) | Carbomedics, Inc. | 1993-12-10 |
| DUROMEDICS CARDIAC VALVE SIZER SET (K853313) | Hemex Scientific, Inc. | 1985-11-01 |
| METRONIC MODEL F7700 HEART VALVE SIZERS (K852612) | Medtronic Vascular | 1985-09-23 |
| MITRAL VALVE ORIFICE SIZER (K820887) | Celtech | 1982-07-08 |
| HANCOCK * OBTURATORS (K801885) | Hancock Laboratories, Inc. | 1980-09-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |