Edwards-Duromedics Mitral Valve Rotator
FDA 510(k) K880052 · Baxter Healthcare Corp
510(k) numberK880052
Submission
- Device name
- Edwards-Duromedics Mitral Valve Rotator
- Applicant
- Baxter Healthcare Corp
Santa Ana, CA, US - Received
- January 6, 1988
- Decision date
- April 1, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTJ – Holder, Heart-Valve, Prosthesis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3935
- Specialty
- Cardiovascular
Other 510(k)s with product code DTJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962154 | Carbomedics HandleDTJ · Traditional | Carbomedics, Inc. | 08/27/1996SE |
| K960169 | Carbomedics Valve TesterDTJ · Traditional | Carbomedics, Inc. | 04/15/1996SE |
| K944214 | Baxter Handle Model 1150DTJ · Traditional | Baxter Edwards | 02/10/1995SE |
| K942736 | Carbomedics(R) Prosthetic Heart Valve Holder HandleDTJ · Traditional | Carbomedics, Inc. | 07/06/1994SE |
| K871596 | Ionescu-Shiley Pericardial Xenograft (Isu)DTJ · Traditional | Shiley, Inc. | 06/15/1987SE |
| K864155 | Modification of Carpentier-Edwards BioprosthesisDTJ · Traditional | American Edwards Laboratories | 11/20/1986SE |
| K813276 | Ionescu-Shiley Valve Holder & HandleDTJ · Traditional | Shiley, Inc. | 12/10/1981SE |
| K811236 | Disposable Holder for Hancock AorticDTJ · Traditional | Vascor, Inc. | 05/13/1981SE |
| K811235 | Disposable Holder for Hancock MitralDTJ · Traditional | Vascor, Inc. | 05/13/1981SE |
| K792034 | Integral Disposable Holder CarpentierDTJ · Traditional | Edwards Laboratories | 12/07/1979SE |
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Questions and answers
When was Edwards-Duromedics Mitral Valve Rotator cleared by the FDA?
Edwards-Duromedics Mitral Valve Rotator (K880052) received a 510(k) decision of Substantially Equivalent on April 1, 1988, 86 days after the submission was received.
What is the product code of K880052?
The FDA product code is DTJ – Holder, Heart-Valve, Prosthesis, a Class I (low risk) device regulated under 21 CFR 870.3935.