Medtrac VP Volumetric Infusion Pump
FDA 510(k) K864997 · American Edwards Laboratories
510(k) numberK864997
Submission
- Device name
- Medtrac VP Volumetric Infusion Pump
- Applicant
- American Edwards Laboratories
Santa Ana, CA, US - Received
- December 22, 1986
- Decision date
- February 27, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional | Deka R&D Corp | 07/24/2026SE |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN · Traditional | Koru Medical Systems, Inc. | 01/28/2026SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
| K243855 | BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional | Carefusion 303, Inc. | 04/25/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K873485 | Edslab (R) Occlusion Balloon CatheterDQY · Traditional | 12/03/1987SE |
| K872596 | Trantec Disposable Pressure TRANS.53-600/F/F30DRS · Traditional | 09/30/1987SE |
| K872529 | Thermodilution Cardiac Output Computer, Mod. COM-2DXG · Traditional | 09/15/1987SE |
| K870444 | Homepro II Volumetric Infusion PumpFRN · Traditional | 04/17/1987SE |
| K864330 | Shear Force GaugeDXE · Traditional | 01/06/1987SE |
| K862724 | Vein Valve CutterDQY · Traditional | 01/02/1987SE |
| K864155 | Modification of Carpentier-Edwards BioprosthesisDTJ · Traditional | 11/20/1986SE |
| K863596 | Chin-Fogarty Inflation DeviceDXT · Traditional | 11/20/1986SE |
| K863986 | Xenon Light Source for Endoscopic ProceduresHRX · Traditional | 10/31/1986SE |
| K862872 | Flexible Visualization CatheterFEI · Traditional | 10/24/1986SE |
Questions and answers
When was Medtrac VP Volumetric Infusion Pump cleared by the FDA?
Medtrac VP Volumetric Infusion Pump (K864997) received a 510(k) decision of Substantially Equivalent on February 27, 1987, 67 days after the submission was received.
What is the product code of K864997?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.