H-Flow Valve
FDA 510(k) K034043 · Elcam Medical Acal
510(k) numberK034043
Submission
- Device name
- H-Flow Valve
- Applicant
- Elcam Medical Acal
Mp. Merom Hagalil, IL - Received
- December 29, 2003
- Decision date
- June 30, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was H-Flow Valve cleared by the FDA?
H-Flow Valve (K034043) received a 510(k) decision of Substantially Equivalent on June 30, 2004, 184 days after the submission was received.
What is the product code of K034043?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.