The following data is part of a premarket notification filed by Invatec S.p.a. with the FDA for Reef Hp 0.035 Otw Pta Balloon Dilatation Catheter.
| Device ID | K092361 |
| 510k Number | K092361 |
| Device Name: | REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | INVATEC S.P.A. 3101 EMRICK BLVD Bethlehem, PA 18020 |
| Contact | John Clay |
| Correspondent | John Clay INVATEC S.P.A. 3101 EMRICK BLVD Bethlehem, PA 18020 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2009-10-29 |
| Summary: | summary |