Metronic Model F7700 Heart Valve Sizers
FDA 510(k) K852612 · Medtronic Vascular
510(k) numberK852612
Submission
- Device name
- Metronic Model F7700 Heart Valve Sizers
- Applicant
- Medtronic Vascular
Minneapolis, MN, US - Received
- June 19, 1985
- Decision date
- September 23, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTI – Sizer, Heart-Valve, Prosthesis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3945
- Specialty
- Cardiovascular
Other 510(k)s with product code DTI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952184 | Carbomedics Supra-Annular Valve SizerDTI · Traditional | Carbomedics, Inc. | 11/29/1995SE |
| K934951 | Valve SizerDTI · Traditional | Carbomedics, Inc. | 12/10/1993SE |
| K881279 | Edwards-Duromedics Bileaflet Valve Sizer SetDTI · Traditional | Baxter Healthcare Corp | 05/18/1988SE |
| K853313 | Duromedics Cardiac Valve Sizer SetDTI · Traditional | Hemex Scientific, Inc. | 11/01/1985SE |
| K820887 | Mitral Valve Orifice SizerDTI · Traditional | Celtech | 07/08/1982SE |
| K801885 | Hancock * ObturatorsDTI · Traditional | Hancock Laboratories, Inc. | 09/09/1980SE |
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Questions and answers
When was Metronic Model F7700 Heart Valve Sizers cleared by the FDA?
Metronic Model F7700 Heart Valve Sizers (K852612) received a 510(k) decision of Substantially Equivalent on September 23, 1985, 96 days after the submission was received.
What is the product code of K852612?
The FDA product code is DTI – Sizer, Heart-Valve, Prosthesis, a Class I (low risk) device regulated under 21 CFR 870.3945.