The following data is part of a premarket notification filed by Elcam Medical A.c.a.l. with the FDA for Haskal Torque Device.
| Device ID | K100425 |
| 510k Number | K100425 |
| Device Name: | HASKAL TORQUE DEVICE |
| Classification | Wire, Guide, Catheter |
| Applicant | ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM Mp. Merom Hagalil, IL 13860 |
| Contact | Shay Shaham |
| Correspondent | Shay Shaham ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM Mp. Merom Hagalil, IL 13860 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-06-17 |
| Summary: | summary |