Ionescu-Shiley Valve Holder & Handle
FDA 510(k) K813276 · Shiley, Inc.
510(k) numberK813276
Submission
- Device name
- Ionescu-Shiley Valve Holder & Handle
- Applicant
- Shiley, Inc.
Walker, MI, US - Received
- November 23, 1981
- Decision date
- December 10, 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 |
| 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 |
More from Edwards Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K920594 | Shiley Perfusion Tubing SetsDTM · Traditional | 03/18/1993SE |
| K910991 | Shiley Therapeutic Autotransfusion SystemCAC · Traditional | 11/27/1991SE |
| K911876 | Shiley Plexus(R) Venous Reservoir, PVR1200DTN · Traditional | 08/09/1991SE |
| K910923 | BCD AdvancedDTR · Traditional | 04/09/1991SE |
| K901548 | Biomedical Sensors-Shiley BGM 4000 Intra Blood GasCCC · Traditional | 01/14/1991SE |
| K903435 | Shiley Specialized Tracheostomy TubeJOH · Traditional | 10/02/1990SE |
| K901624 | Shiley Plexus Integral Reservoir Hollow Fiber Oxy.DTZ · Traditional | 07/03/1990SE |
| K901250 | Plexus 2(TM) Infant Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K901249 | Plexus 3.5(TM) Pediatric Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | 05/10/1990SE |
Questions and answers
When was Ionescu-Shiley Valve Holder & Handle cleared by the FDA?
Ionescu-Shiley Valve Holder & Handle (K813276) received a 510(k) decision of Substantially Equivalent on December 10, 1981, 17 days after the submission was received.
What is the product code of K813276?
The FDA product code is DTJ – Holder, Heart-Valve, Prosthesis, a Class I (low risk) device regulated under 21 CFR 870.3935.