Rmi Hemoconcentractor Tubing Set
FDA 510(k) K961927 · Research Medical, Inc.
510(k) numberK961927
Submission
- Device name
- Rmi Hemoconcentractor Tubing Set
- Applicant
- Research Medical, Inc.
Midvale, UT, US - Received
- May 17, 1996
- Decision date
- August 13, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4210
- Specialty
- Cardiovascular
Other 510(k)s with product code DWF
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|---|---|---|---|
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial CannulaeDWF · Special | Medtronic, Inc. | 04/23/2026SE |
| K250937 | Venous Return CannulaeDWF · Traditional | LivaNova USA, Inc. | 03/11/2026SE |
| K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)DWF · Traditional | Smart Reactors | 02/23/2026SE |
| K253203 | Retrograde Coronary Sinus Perfusion CannulaeDWF · Traditional | Medtronic, Inc. | 02/19/2026SE |
| K253671 | Dual Stage Venous CannulaeDWF · Traditional | Sorin Group Italia S.R.L. | 01/30/2026SE |
| K253998 | Clearview Intracoronary ShuntsDWF · Special | Medtronic, Inc. | 01/20/2026SE |
| K253106 | AngioVac CannulaDWF · Special | AngioDynamics, Inc. | 10/24/2025SE |
| K250283 | RAP Femoral Venous CannulaeDWF · Special | LivaNova USA, Inc. | 07/10/2025SE |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)DWF · Special | Sorin Group Italia S.R.L. | 06/27/2025SE |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous CannulaDWF · Traditional | Medtronic, Inc. | 06/20/2025SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970739 | Rmi Hemoconcentrator Preference PackKDI · Traditional | 07/08/1997SE |
| K964833 | Rmi Dual Fluid Irrigating SyringeKYZ · Traditional | 02/19/1997SE |
| K960098 | Rmi Internal Mammary Artery CannulaDQR · Traditional | 03/26/1996SE |
| K951344 | Rmi HemoconcentratorKDI · Traditional | 08/15/1995SE |
| K922083 | Rmi Surgiccal Site Visualization WandFQH · Traditional | 01/29/1993SE |
| K920936 | Rmi External Coronary Artery OccluderDXC · Traditional | 12/18/1992SE |
| K915869 | Rmi Normocluder Coronary Artery OccluderMJN · Traditional | 12/08/1992SE |
| K920676 | Rmi SofclampDSS · Traditional | 04/15/1992SE |
| K910221 | Rmi Vascular Tourniquet KitDXC · Traditional | 05/16/1991SE |
| K901231 | Rmi Cardioplegia Delivery KitsDWF · Traditional | 06/08/1990SE |
Questions and answers
When was Rmi Hemoconcentractor Tubing Set cleared by the FDA?
Rmi Hemoconcentractor Tubing Set (K961927) received a 510(k) decision of Substantially Equivalent on August 13, 1996, 88 days after the submission was received.
What is the product code of K961927?
The FDA product code is DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4210.