FDA Product Code
FDA Product Code DTI — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3945
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K952184 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | Carbomedics, Inc. | 1995-11-29 | Traditional | PDF ↗ |
| K934951 | VALVE SIZER | Carbomedics, Inc. | 1993-12-10 | Traditional | PDF ↗ |
| K881279 | EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET | Baxter Healthcare Corp | 1988-05-18 | Traditional | PDF ↗ |
| K853313 | DUROMEDICS CARDIAC VALVE SIZER SET | Hemex Scientific, Inc. | 1985-11-01 | Traditional | PDF ↗ |
| K852612 | METRONIC MODEL F7700 HEART VALVE SIZERS | Medtronic Vascular | 1985-09-23 | Traditional | PDF ↗ |
| K820887 | MITRAL VALVE ORIFICE SIZER | Celtech | 1982-07-08 | Traditional | PDF ↗ |
| K801885 | HANCOCK * OBTURATORS | Hancock Laboratories, Inc. | 1980-09-09 | Traditional | PDF ↗ |
Product code DTI · Class I · Cardiovascular. Data: openFDA.