Rmi Hemoconcentrator Preference Pack
FDA 510(k) K970739 · Research Medical, Inc.
510(k) numberK970739
Submission
- Device name
- Rmi Hemoconcentrator Preference Pack
- Applicant
- Research Medical, Inc.
Midvale, UT, US - Received
- February 28, 1997
- Decision date
- July 8, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K964833 | Rmi Dual Fluid Irrigating SyringeKYZ · Traditional | 02/19/1997SE |
| K961927 | Rmi Hemoconcentractor Tubing SetDWF · Traditional | 08/13/1996SE |
| 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 Hemoconcentrator Preference Pack cleared by the FDA?
Rmi Hemoconcentrator Preference Pack (K970739) received a 510(k) decision of Substantially Equivalent on July 8, 1997, 130 days after the submission was received.
What is the product code of K970739?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.