Rowe Dual-Check Valve
FDA 510(k) K983217 · Cook, Inc.
510(k) numberK983217
Submission
- Device name
- Rowe Dual-Check Valve
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- September 14, 1998
- Decision date
- January 20, 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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Questions and answers
When was Rowe Dual-Check Valve cleared by the FDA?
Rowe Dual-Check Valve (K983217) received a 510(k) decision of Substantially Equivalent on January 20, 1999, 128 days after the submission was received.
What is the product code of K983217?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.