Edwards-Duromedics Bileaflet Valve Sizer Set
FDA 510(k) K881279 · Baxter Healthcare Corp
510(k) numberK881279
Submission
- Device name
- Edwards-Duromedics Bileaflet Valve Sizer Set
- Applicant
- Baxter Healthcare Corp
Santa Ana, CA, US - Received
- March 22, 1988
- Decision date
- May 18, 1988
- 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 |
| 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 |
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Questions and answers
When was Edwards-Duromedics Bileaflet Valve Sizer Set cleared by the FDA?
Edwards-Duromedics Bileaflet Valve Sizer Set (K881279) received a 510(k) decision of Substantially Equivalent on May 18, 1988, 57 days after the submission was received.
What is the product code of K881279?
The FDA product code is DTI – Sizer, Heart-Valve, Prosthesis, a Class I (low risk) device regulated under 21 CFR 870.3945.