Modified RLV-2100 B
FDA 510(k) K864503 · American Omni Medical, Inc.
510(k) numberK864503
Submission
- Device name
- Modified RLV-2100 B
- Applicant
- American Omni Medical, Inc.
Costa Mesa, CA, US - Received
- November 14, 1986
- Decision date
- January 6, 1987
- 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 |
| K863593 | Sarns Safety LoopDWD · Traditional | 3M Health Care, Sarns | 11/18/1986SE |
| K862540 | Left Ventricular Vent Valve Model No. GLVDWD · Traditional | Gish Biomedical, Inc. | 08/29/1986SE |
| K861428 | Suction Control Valve (Nonadjustable) CAT.RLV-2100DWD · Traditional | American Omni Medical, Inc. | 06/26/1986SE |
More from American Omni Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922781 | Flow Conrol ValveMJJ · Traditional | 03/08/1993SE |
| K922356 | Flow Control Valve, Cat. No. ACV-38MJJ · Traditional | 02/12/1993SE |
| K900672 | Prebypass Filter, Cat. No. FPB-5KRJ · Traditional | 04/03/1990SE |
| K884893 | Cardiotomy Reservoir Valve No. CRV-30 or PCRV-25KRI · Traditional | 01/30/1989SE |
| K884640 | Cardioplegia Overpressure Valve CPOP-350 & 700KRI · Traditional | 01/24/1989SE |
| K873316 | Bubble Trap-Filter Cat. No B180F37DTM · Traditional | 07/14/1988SE |
| K875080 | Air Vent Line Cat. No. AVL-36DTM · Traditional | 02/29/1988SE |
| K873802 | Pressure Barrier Kit Cat. No. PBK-3DXS · Traditional | 11/06/1987SE |
| K873610 | Pediatric Bubble Trap Cat. No. B-100BSY · Traditional | 11/05/1987SE |
| K873488 | Silent Guard Cat. No. SG-10DTL · Traditional | 10/07/1987SE |
Questions and answers
When was Modified RLV-2100 B cleared by the FDA?
Modified RLV-2100 B (K864503) received a 510(k) decision of Substantially Equivalent on January 6, 1987, 53 days after the submission was received.
What is the product code of K864503?
The FDA product code is DWD – Suction Control, Intracardiac, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4430.