Nikkiso NK Pump
FDA 510(k) K920077 · International Medical Products, Inc.
510(k) numberK920077
Submission
- Device name
- Nikkiso NK Pump
- Applicant
- International Medical Products, Inc.
Minneapolis, MN, US - Received
- January 8, 1992
- Decision date
- September 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| 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 |
|---|---|---|
| K981003 | Rockwell Medical Supply, LLC Dri-Sate Acid Concentrate MixesKPO · Traditional | 06/16/1998SE |
| K973253 | Rockwell Medical Supply, LLC Concentrate Solutions for Acetate DialysateKPO · Traditional | 10/30/1997SE |
| K971053 | Rockwell Medical Supply,Llc. Bicarbonate Solution Concentrates for Bicarbonate DialysisKPO · Traditional | 06/16/1997SE |
| K923942 | Rhombo Medical Rhombo-FillKNN · Traditional | 03/24/1993SE |
| K900755 | Digital Cuff PV GaugeBSK · Traditional | 04/26/1990SE |
| K864984 | RobinjectKZE · Traditional | 06/29/1987SE |
| K863609 | Single-Patient Automatic Dialysis Unit Mod. DBB-22FKP · Traditional | 02/25/1987SE |
| K861539 | Nikkiso Infusion Pump Model PFA-02FRN · Traditional | 07/31/1986SE |
Questions and answers
When was Nikkiso NK Pump cleared by the FDA?
Nikkiso NK Pump (K920077) received a 510(k) decision of Substantially Equivalent on September 29, 1993, 630 days after the submission was received.
What is the product code of K920077?
The FDA product code is DWD – Suction Control, Intracardiac, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4430.