The following data is part of a premarket notification filed by Cmt Medical Technologies, Ltd. with the FDA for Fluoro Catheter.
| Device ID | K953950 |
| 510k Number | K953950 |
| Device Name: | FLUORO CATHETER |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | CMT MEDICAL TECHNOLOGIES, LTD. MATAM HIGH TECHNOLOGY CENTER Haifa, IL 31905 |
| Contact | Imre Farkash |
| Correspondent | Imre Farkash CMT MEDICAL TECHNOLOGIES, LTD. MATAM HIGH TECHNOLOGY CENTER Haifa, IL 31905 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-22 |
| Decision Date | 1995-09-18 |