Left Ventricular Vent Valve Model No. GLV
FDA 510(k) K862540 · Gish Biomedical, Inc.
510(k) numberK862540
Submission
- Device name
- Left Ventricular Vent Valve Model No. GLV
- Applicant
- Gish Biomedical, Inc.
Santa Ana, CA, US - Received
- July 2, 1986
- Decision date
- August 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWD – Suction Control, Intracardiac, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4430
- Specialty
- Cardiovascular
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|---|---|---|---|
| K992657 | Ibc VRV, Model 1350DWD · Traditional | International Biophysics Corp. | 02/18/2000SE |
| K920077 | Nikkiso NK PumpDWD · Traditional | International Medical Products, Inc. | 09/29/1993SE |
| K915482 | B-D Ultra-Vue Procedure Needle W/ Westcott Type PTDWD · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/07/1992SE |
| K915481 | B-D Ultra-Vue Procedure Needle W/ Chiba Type PointDWD · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/07/1992SE |
| K915480 | B-D Ultra-Vue Procedure Needle W/ Spinal Type Pt.DWD · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/07/1992SE |
| K905311 | Duraflo II Heparin Treated Suction Wands Var. Mod.DWD · Traditional | Baxter Bentley Laboratories, Inc. | 01/15/1991SE |
| K895427 | Mediseal Suction CanisterDWD · Traditional | Deroyal Industries, Inc. | 01/19/1990SE |
| K864503 | Modified RLV-2100 BDWD · Traditional | American Omni Medical, Inc. | 01/06/1987SE |
| K863593 | Sarns Safety LoopDWD · Traditional | 3M Health Care, Sarns | 11/18/1986SE |
| K861428 | Suction Control Valve (Nonadjustable) CAT.RLV-2100DWD · Traditional | American Omni Medical, Inc. | 06/26/1986SE |
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| K080708 | Vision Hollow Fiber Oxygenator with Ha CoatingDTZ · Traditional | 02/02/2009SE |
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Questions and answers
When was Left Ventricular Vent Valve Model No. GLV cleared by the FDA?
Left Ventricular Vent Valve Model No. GLV (K862540) received a 510(k) decision of Substantially Equivalent on August 29, 1986, 58 days after the submission was received.
What is the product code of K862540?
The FDA product code is DWD – Suction Control, Intracardiac, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4430.