Flexible Intracardiac Suction Device
FDA 510(k) K905008 · Gish Biomedical, Inc.
510(k) numberK905008
Submission
- Device name
- Flexible Intracardiac Suction Device
- Applicant
- Gish Biomedical, Inc.
Santa Ana, CA, US - Received
- November 6, 1990
- Decision date
- January 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4420
- Specialty
- Cardiovascular
Other 510(k)s with product code DTS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053021 | Estech Clearview MV Atrial DepressorDTS · Traditional | Estech, Inc. | 01/26/2006SE |
| K982891 | California Medical Laboratories Inc. Standard and Small Rigid Tip Suction WandsDTS · Traditional | California Medical Laboratories, Inc. | 09/30/1998SE |
| K963756 | Ibc Cardiac Suction WardDTS · Traditional | International Biophysics Corp. | 11/14/1997SE |
| K900339 | Hand-Held Intracardiac Suckers W/Ergonomic HandlesDTS · Traditional | Shiley, Inc. | 03/28/1990SE |
| K891906 | Robicsek Intracardiac Suction WandDTS · Traditional | Gish Biomedical, Inc. | 06/13/1989SE |
| K801641 | Ohio Disposable Clear Suction InstrumentDTS · Traditional | Ohio Medical Products | 07/28/1980SE |
| K801400 | Disposable Sucker SystemDTS · Traditional | Texas Medical Products, Inc. | 06/30/1980SE |
| K791846 | Dispossable Suction Tube, 6 FrenchDTS · Traditional | Dlp, Inc. | 10/02/1979SE |
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| K090450 | Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LTDTZ · Traditional | 09/18/2009SE |
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| K091062 | Medos Hilite Infant Reservoir, Model MVC 0730DTN · Traditional | 08/04/2009SE |
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| K082403 | Medos Hilite Oxygenator, Model 7000 & 7000 LTDTZ · Traditional | 05/15/2009SE |
| K082082 | Gish SVR Soft Venous Reservoirs with Ha CoatingDTN · Traditional | 02/04/2009SE |
| K081947 | Gish CAPVRF44 Hardshell Venous Reservoir with Ha CoatingDTN · Traditional | 02/04/2009SE |
| K080708 | Vision Hollow Fiber Oxygenator with Ha CoatingDTZ · Traditional | 02/02/2009SE |
| K081838 | Gish Vision Blood Cardioplegia with Ha CoatingDTR · Traditional | 01/26/2009SE |
| K081881 | Gish Tubing and Connectors with Ha CoatingDWF · Traditional | 01/23/2009SE |
Questions and answers
When was Flexible Intracardiac Suction Device cleared by the FDA?
Flexible Intracardiac Suction Device (K905008) received a 510(k) decision of Substantially Equivalent on January 23, 1991, 78 days after the submission was received.
What is the product code of K905008?
The FDA product code is DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4420.