K034043 is an FDA 510(k) clearance for the H-FLOW VALVE. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Elcam Medical Acal (Mp. Merom Hagalil, IL). The FDA issued a Cleared decision on June 30, 2004, 184 days after receiving the submission on December 29, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K034043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2003 |
| Decision Date | June 30, 2004 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO - Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |