The following data is part of a premarket notification filed by Elcam Medical A.c.a.l. with the FDA for H-flow Valve.
| Device ID | K034043 |
| 510k Number | K034043 |
| Device Name: | H-FLOW VALVE |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
| Contact | Tali Hazan |
| Correspondent | Tali Hazan ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-29 |
| Decision Date | 2004-06-30 |
| Summary: | summary |