Disposable Holder for Hancock Mitral
FDA 510(k) K811235 · Vascor, Inc.
510(k) numberK811235
Submission
- Device name
- Disposable Holder for Hancock Mitral
- Applicant
- Vascor, Inc.
Walker, MI, US - Received
- May 4, 1981
- Decision date
- May 13, 1981
- 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 |
| K880052 | Edwards-Duromedics Mitral Valve RotatorDTJ · Traditional | Baxter Healthcare Corp | 04/01/1988SE |
| 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 |
| K792034 | Integral Disposable Holder CarpentierDTJ · Traditional | Edwards Laboratories | 12/07/1979SE |
More from Edwards Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K811236 | Disposable Holder for Hancock AorticDTJ · Traditional | 05/13/1981SE |
Questions and answers
When was Disposable Holder for Hancock Mitral cleared by the FDA?
Disposable Holder for Hancock Mitral (K811235) received a 510(k) decision of Substantially Equivalent on May 13, 1981, 9 days after the submission was received.
What is the product code of K811235?
The FDA product code is DTJ – Holder, Heart-Valve, Prosthesis, a Class I (low risk) device regulated under 21 CFR 870.3935.