Duraflo II Heparin Treated Suction Wands Var. Mod.
FDA 510(k) K905311 · Baxter Bentley Laboratories, Inc.
510(k) numberK905311
Submission
- Device name
- Duraflo II Heparin Treated Suction Wands Var. Mod.
- Applicant
- Baxter Bentley Laboratories, Inc.
Irvine, CA, US - Received
- November 28, 1990
- Decision date
- January 15, 1991
- 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
Other 510(k)s with product code DWD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Questions and answers
When was Duraflo II Heparin Treated Suction Wands Var. Mod. cleared by the FDA?
Duraflo II Heparin Treated Suction Wands Var. Mod. (K905311) received a 510(k) decision of Substantially Equivalent on January 15, 1991, 48 days after the submission was received.
What is the product code of K905311?
The FDA product code is DWD – Suction Control, Intracardiac, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4430.