Kvo Check Valve Accessory, Model EV-0001
FDA 510(k) K984441 · I-Flow Corp.
510(k) numberK984441
Submission
- Device name
- Kvo Check Valve Accessory, Model EV-0001
- Applicant
- I-Flow Corp.
Lake Forest, CA, US - Received
- December 14, 1998
- Decision date
- February 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K023883 | Homepump, Eclipse, C-Series, Painbuster, C-Bloc, On-Q, Easypump, KvoMEB · Special | 12/20/2002SE |
| K023827 | Paragon Infusion System with BolusFRN · Special | 12/13/2002SE |
| K023318 | I-Flow Elastomeric Pump with BolusMEB · Special | 10/18/2002SE |
Questions and answers
When was Kvo Check Valve Accessory, Model EV-0001 cleared by the FDA?
Kvo Check Valve Accessory, Model EV-0001 (K984441) received a 510(k) decision of Substantially Equivalent on February 22, 1999, 70 days after the submission was received.
What is the product code of K984441?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.