Disposable Holder for Bioprosthesis
FDA 510(k) K790022 · Edwards Laboratories
510(k) numberK790022
Submission
- Device name
- Disposable Holder for Bioprosthesis
- Applicant
- Edwards Laboratories
Mchenry, IL, US - Received
- January 3, 1979
- Decision date
- January 15, 1979
- 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 |
| K811235 | Disposable Holder for Hancock MitralDTJ · Traditional | Vascor, Inc. | 05/13/1981SE |
More from Vascor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K801552 | Mod. 9542 Flow-Thru Inject. Temp. SensorKRB · Traditional | 07/28/1980SE |
| K800655 | Model 100 SpectraviewDQC · Traditional | 04/16/1980SE |
| K792441 | Carpentier-Edwards Flex. AnnuloplastyKRH · Traditional | 03/17/1980PT |
| K792034 | Integral Disposable Holder CarpentierDTJ · Traditional | 12/07/1979SE |
| K790047 | Cardiac Output Computer, Mdel 9520ADXG · Traditional | 02/26/1979SE |
| K781535 | Ac Adapter:Models 9525,9526,9527DXG · Traditional | 09/15/1978SE |
| K771663 | Probe & CatheterKRB · Traditional | 09/20/1977SE |
| K771046 | Vena Cava Umbrella Filter, Model 7321DTK · Traditional | 06/22/1977SE |
| K760151 | Applicator,Angiography (7310MOBIN-UDDIN)DTK · Traditional | 08/26/1976SE |
| K760192 | Computer, Thermodilution Cardiac (9520)DXG · Traditional | 07/19/1976SE |
Questions and answers
When was Disposable Holder for Bioprosthesis cleared by the FDA?
Disposable Holder for Bioprosthesis (K790022) received a 510(k) decision of Substantially Equivalent on January 15, 1979, 12 days after the submission was received.
What is the product code of K790022?
The FDA product code is DTJ – Holder, Heart-Valve, Prosthesis, a Class I (low risk) device regulated under 21 CFR 870.3935.