The following data is part of a premarket notification filed by Natec Medical Ltd with the FDA for Ebony Pta 0.014'' Over The Wire Catheter And Ebony Pta 0.018 Over The Wire Catheter.
| Device ID | K143041 |
| 510k Number | K143041 |
| Device Name: | Ebony PTA 0.014'' Over The Wire Catheter And Ebony PTA 0.018 Over The Wire Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Natec Medical Ltd Maeva Centre Building Ebene Business Park Reduit, MU 72201 |
| Contact | Xavier De Buchere |
| Correspondent | Xavier De Buchere CardioMed Device Consultants, LLC Maeva Centre Building - Silicon Avenue Ebene Business Park Reduit, Mauritius, MU 72201 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-22 |
| Decision Date | 2015-06-04 |
| Summary: | summary |