The following data is part of a premarket notification filed by Natec Medical Ltd with the FDA for Ebony Pta .035 Peripheral Dilatation Catheter.
| Device ID | K103354 |
| 510k Number | K103354 |
| Device Name: | EBONY PTA .035 PERIPHERAL DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | NATEC MEDICAL LTD 1468 Harwell Avenue Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith NATEC MEDICAL LTD 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-16 |
| Decision Date | 2011-02-23 |
| Summary: | summary |