DTI · Sizer, Heart-Valve, Prosthesis
Cardiovascular · 21 CFR 870.3945 · Class 1
Overview
| Product Code | DTI |
|---|---|
| Device Name | Sizer, Heart-Valve, Prosthesis |
| Regulation | 21 CFR 870.3945 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
A prosthetic heart valve sizer is a device used to measure the size of the natural valve opening to determine the size of the appropriate replacement heart valve.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952184 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | Carbomedics, Inc. | Nov 29, 1995 | SESE |
| K934951 | VALVE SIZER | Carbomedics, Inc. | Dec 10, 1993 | SESE |
| K881279 | EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET | Baxter Healthcare Corp | May 18, 1988 | SESE |
| K853313 | DUROMEDICS CARDIAC VALVE SIZER SET | Hemex Scientific, Inc. | Nov 1, 1985 | SESE |
| K852612 | METRONIC MODEL F7700 HEART VALVE SIZERS | Medtronic Vascular | Sep 23, 1985 | SESE |
| K820887 | MITRAL VALVE ORIFICE SIZER | Celtech | Jul 8, 1982 | SESE |
| K801885 | HANCOCK * OBTURATORS | Hancock Laboratories, Inc. | Sep 9, 1980 | SESE |
Top Applicants
- Carbomedics, Inc. — 2 clearances
- Baxter Healthcare Corp — 1 clearance
- Celtech — 1 clearance
- Hancock Laboratories, Inc. — 1 clearance
- Hemex Scientific, Inc. — 1 clearance
