Carbomedics Supra-Annular Valve Sizer
FDA 510(k) K952184 · Carbomedics, Inc.
510(k) numberK952184
Submission
- Device name
- Carbomedics Supra-Annular Valve Sizer
- Applicant
- Carbomedics, Inc.
Austin, TX, US - Received
- May 9, 1995
- Decision date
- November 29, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K852612 | Metronic Model F7700 Heart Valve SizersDTI · Traditional | Medtronic Vascular | 09/23/1985SE |
| K820887 | Mitral Valve Orifice SizerDTI · Traditional | Celtech | 07/08/1982SE |
| K801885 | Hancock * ObturatorsDTI · Traditional | Hancock Laboratories, Inc. | 09/09/1980SE |
More from Hancock Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970375 | Annuloflo SystemKRH · Traditional | 07/25/1997ST |
| K964665 | Vascutek Gelweave Vascular Graft (Bifurcated Configuration)DSY · Traditional | 02/19/1997ST |
| K962154 | Carbomedics HandleDTJ · Traditional | 08/27/1996SE |
| K960923 | Carbomedics Mitral RotatorMOP · Traditional | 04/29/1996SE |
| K960706 | Vascutek Vascusoft Plus Vascular GraftDSY · Traditional | 04/25/1996SESP |
| K960169 | Carbomedics Valve TesterDTJ · Traditional | 04/15/1996SE |
| K955588 | Vascutek Graft Sizer SetDSY · Traditional | 03/07/1996ST |
| K951368 | Carbomedics Exended Mitral RotatorMOP · Traditional | 06/20/1995SE |
| K942736 | Carbomedics(R) Prosthetic Heart Valve Holder HandleDTJ · Traditional | 07/06/1994SE |
| K934951 | Valve SizerDTI · Traditional | 12/10/1993SE |
Questions and answers
When was Carbomedics Supra-Annular Valve Sizer cleared by the FDA?
Carbomedics Supra-Annular Valve Sizer (K952184) received a 510(k) decision of Substantially Equivalent on November 29, 1995, 204 days after the submission was received.
What is the product code of K952184?
The FDA product code is DTI – Sizer, Heart-Valve, Prosthesis, a Class I (low risk) device regulated under 21 CFR 870.3945.