The following data is part of a premarket notification filed by Natec Medical Ltd with the FDA for Ebony Pta 0.014 Rx Peripheral Dilatation Catheter.
| Device ID | K142459 |
| 510k Number | K142459 |
| Device Name: | Ebony PTA 0.014 RX Peripheral Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | NATEC MEDICAL LTD MAEVA CENTRE BUILDING EBENE BUSINESS PARK Reduit, MU 72201 |
| Contact | Xavier De Buchere |
| Correspondent | Judith Danielson CARDIOMED DEVICE CONSULTANTS, LLC 5523 RESEARCH PARK DRIVE SUITE 205 Baltimore, MD 21228 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-02 |
| Decision Date | 2015-02-03 |
| Summary: | summary |