The following data is part of a premarket notification filed by Natec Medical Ltd. with the FDA for Ebony Hp Pta Otw 0.035 Catheter.
| Device ID | K220410 |
| 510k Number | K220410 |
| Device Name: | Ebony HP PTA OTW 0.035 Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Natec Medical Ltd. Maeva Centre Building, Silicon Avenue, Ebene Business Park Reduit, MU 72201 |
| Contact | Roy Devassy Pallippatt |
| Correspondent | Roy Pallippatt Natec Medical Ltd. Maeva Centre Building, Silicon Avenue, Ebene Business Park Reduit, MU 72201 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-14 |
| Decision Date | 2022-06-29 |