IV Admin. Set for MVP 1 Infusion Pump
FDA 510(k) K843311 · Ziehm International, Inc.
510(k) numberK843311
Submission
- Device name
- IV Admin. Set for MVP 1 Infusion Pump
- Applicant
- Ziehm International, Inc.
7600 Ridge Blvd Brooklun, NY, US - Received
- August 23, 1984
- Decision date
- March 13, 1985
- 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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| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
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| 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 |
|---|---|---|
| K011292 | Ziehm VisionOWB · Traditional | 06/20/2001SE |
| K910455 | Ims Disposable Holder with Needle RetractorFMI · Traditional | 02/14/1991SE |
| K902196 | Modified Stick-Gard Safety NeedleFPA · Traditional | 06/26/1990SE |
| K894021 | Mobile X-Ray UnitIZL · Traditional | 09/01/1989SE |
| K894041 | Pump-Ject Syringe with Luer-LockFRN · Traditional | 08/28/1989SE |
| K890620 | Stick-Gard Safety NeedleFMI · Traditional | 02/28/1989SE |
| K882133 | Mammo MIZH · Traditional | 09/19/1988SE |
| K842263 | MTP E.V. Infusion PumpFRN · Traditional | 07/25/1984SE |
| K831407 | Cardiac Output ComputerDXG · Traditional | 10/14/1983SE |
| K830453 | IV Administration Sets - MVP InfusionFPA · Traditional | 04/30/1983SE |
Questions and answers
When was IV Admin. Set for MVP 1 Infusion Pump cleared by the FDA?
IV Admin. Set for MVP 1 Infusion Pump (K843311) received a 510(k) decision of Substantially Equivalent on March 13, 1985, 202 days after the submission was received.
What is the product code of K843311?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.