Coeur Front Load Injector Retrofit Kit (C859-0002)
FDA 510(k) K965214 · Coeur Laboratories, Inc.
510(k) numberK965214
Submission
- Device name
- Coeur Front Load Injector Retrofit Kit (C859-0002)
- Applicant
- Coeur Laboratories, Inc.
Raleigh, NC, US - Received
- December 30, 1996
- Decision date
- March 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTX – Gas Control Unit, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K101046 | Stockert S5 System and Gas Blender and Sorin C5 SystemDTX · Traditional | Sorin Group Deutschland GmbH | 12/09/2010SE |
| K023745 | Sechrist Air/Oxygen Mixer, Model 3500 Cp-GDTX · Traditional | Sechrist Industries, Inc. | 01/17/2003SE |
| K863902 | Modified Sarns Membrane OxygenatorDTX · Traditional | 3M Health Care, Sarns | 12/11/1986SE |
| K822820 | Gas-Flow Meter GFL 10DTX · Traditional | Gambro, Inc. | 10/18/1982SE |
| K792348 | Stanicor, Omni-Stan,Mod 333B,334A GammaDTX · Traditional | Cordis Corp. | 12/05/1979SE |
| K790546 | Flowmeter, Optiflo GasDTX · Traditional | Cobe Laboratories, Inc. | 05/11/1979SE |
More from Cobe Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971712 | Coeur 130 ML Angiographic SyringeDXT · Traditional | 10/08/1997SE |
| K960965 | Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211DXT · Traditional | 09/12/1996SE |
| K890292 | PCA-10, 10CC Disp. Angiography Control SyringeDXT · Traditional | 06/22/1989SE |
| K885138 | Capillary Tube, Blood CollectionGIO · Traditional | 02/07/1989SE |
| K885202 | 16 Long Catheter W/Adapter, 14 FR and 12 FRKOD · Traditional | 01/31/1989SE |
| K881646 | Urological CatheterKOD · Traditional | 06/16/1988SE |
| K874579 | Coeur Control SyringeFMF · Traditional | 01/19/1988SE |
| K873597 | Tubing, PolyethyleneDXT · Traditional | 11/12/1987SE |
| K823920 | Coeurlock Sterile Dispos. AngiographicDXT · Traditional | 02/18/1983SE |
Questions and answers
When was Coeur Front Load Injector Retrofit Kit (C859-0002) cleared by the FDA?
Coeur Front Load Injector Retrofit Kit (C859-0002) (K965214) received a 510(k) decision of Substantially Equivalent on March 28, 1997, 88 days after the submission was received.
What is the product code of K965214?
The FDA product code is DTX – Gas Control Unit, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4300.