The following data is part of a premarket notification filed by Natec Medical with the FDA for Ebony Pta .014 Rx Pheripheral Dilatation Catheter.
| Device ID | K152230 |
| 510k Number | K152230 |
| Device Name: | Ebony PTA .014 RX Pheripheral Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | NATEC MEDICAL MAEVA CENTRE BUILDING, SILICON AVENUE, 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-07 |
| Decision Date | 2015-09-03 |
| Summary: | summary |