DTI — Sizer, Heart-Valve, Prosthesis Class I
FDA product code DTI covers "Sizer, Heart-Valve, Prosthesis", a Class I medical device regulated under 21 CFR 870.3945. Submissions are reviewed by the Cardiovascular panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DTI
- Device Class
- Class I
- Regulation Number
- 870.3945
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K952184 | carbomedics | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | November 29, 1995 |
| K934951 | carbomedics | VALVE SIZER | December 10, 1993 |
| K881279 | baxter healthcare | EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET | May 18, 1988 |
| K853313 | hemex scientific | DUROMEDICS CARDIAC VALVE SIZER SET | November 1, 1985 |
| K852612 | medtronic vascular | METRONIC MODEL F7700 HEART VALVE SIZERS | September 23, 1985 |
| K820887 | celtech | MITRAL VALVE ORIFICE SIZER | July 8, 1982 |
| K801885 | hancock laboratories | HANCOCK * OBTURATORS | September 9, 1980 |