The following data is part of a premarket notification filed by Natec Medical Ltd with the FDA for Filao Nc Rx Ptca Dilatation Catheter.
| Device ID | K141933 |
| 510k Number | K141933 |
| Device Name: | FILAO NC RX PTCA DILATATION CATHETER |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | NATEC MEDICAL LTD 5523 RESEARCH PARK DRIVE, SUITE 205 Baltimore, MD 21228 |
| Contact | Judith Danielson |
| Correspondent | Xavier De Buchere NATEC MEDICAL LTD Maeva Centre Building Silicon Avenue Reduit 72201, MU |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-16 |
| Decision Date | 2015-06-28 |
| Summary: | summary |