River Pump
FDA 510(k) K932895 · River Medical, Inc.
510(k) numberK932895
Submission
- Device name
- River Pump
- Applicant
- River Medical, Inc.
San Diego, CA, US - Received
- June 14, 1993
- Decision date
- March 31, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K023174 | Disposable Temporary Pacing WireLDF · Traditional | 06/11/2003SE |
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| K944351 | Smartdose IV Prefilled Infusion ContainerFRN · Traditional | 11/15/1995ST |
| K945298 | Smartflow I Administration SetFPA · Traditional | 06/14/1995SE |
| K943692 | Smart Dose(Tm)FRN · Traditional | 04/28/1995ST |
| K933335 | River Vial AdapterFMF · Traditional | 03/01/1994SE |
| K915120 | Tef/Platinum PistonETB · Traditional | 12/27/1991SE |
| K915121 | Tef/Wire PistonETB · Traditional | 12/23/1991SE |
| K913287 | H/A Partial - Regular & H/A Partial - OffsetETB · Traditional | 12/18/1991SE |
| K913286 | H/A Total-Regular, H/A Total-OffsetETA · Traditional | 12/18/1991SE |
Questions and answers
When was River Pump cleared by the FDA?
River Pump (K932895) received a 510(k) decision of Substantially Equivalent on March 31, 1994, 290 days after the submission was received.
What is the product code of K932895?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.