Sizer, Heart-Valve, Prosthesis
The Heart-Valve Prosthesis Sizer is a cardiovascular surgical instrument used intraoperatively to measure the size of the native valve annulus, enabling the surgeon to select the appropriate prosthetic heart valve for implantation. It is classified as an FDA Class 1 device, representing the lowest level of regulatory concern, and is subject to general controls only. The product code is DTI and it is regulated under 21 CFR 870.3945 within the Cardiovascular medical specialty.
Basic Information
- Product Code
- DTI
- Device Class
- FDA class 1
- Regulation Number
- 870.3945
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K952184 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | Nov 29, 1995 | Substantially Equivalent | Carbomedics, Inc. |
| K934951 | VALVE SIZER | Dec 10, 1993 | Substantially Equivalent | Carbomedics, Inc. |
| K881279 | EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET | May 18, 1988 | Substantially Equivalent | Baxter Healthcare Corp |
| K853313 | DUROMEDICS CARDIAC VALVE SIZER SET | Nov 01, 1985 | Substantially Equivalent | Hemex Scientific, Inc. |
| K852612 | METRONIC MODEL F7700 HEART VALVE SIZERS | Sep 23, 1985 | Substantially Equivalent | Medtronic Vascular |
| K820887 | MITRAL VALVE ORIFICE SIZER | Jul 08, 1982 | Substantially Equivalent | Celtech |
| K801885 | HANCOCK * OBTURATORS | Sep 09, 1980 | Substantially Equivalent | Hancock Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.