The following data is part of a premarket notification filed by Invatec Innovative Technologies, S.r.l. with the FDA for Modification To Amphirion Deep 0.014 Otw Pta Balloon Catheter.
| Device ID | K050073 |
| 510k Number | K050073 |
| Device Name: | MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 4600 Nathan Lane North Plymouth, MN 55442 |
| Contact | Mike Winegar |
| Correspondent | Mike Winegar INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 4600 Nathan Lane North Plymouth, MN 55442 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-12 |
| Decision Date | 2005-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033477050652 | K050073 | 000 |
| 08033477045870 | K050073 | 000 |
| 08033477045894 | K050073 | 000 |
| 08033477045931 | K050073 | 000 |
| 08033477045955 | K050073 | 000 |
| 08033477045979 | K050073 | 000 |
| 08033477046013 | K050073 | 000 |
| 08033477046037 | K050073 | 000 |
| 08033477046051 | K050073 | 000 |
| 08033477046099 | K050073 | 000 |
| 08033477046112 | K050073 | 000 |
| 08033477046136 | K050073 | 000 |
| 08033477050416 | K050073 | 000 |
| 08033477050454 | K050073 | 000 |
| 08033477050478 | K050073 | 000 |
| 08033477050638 | K050073 | 000 |
| 08033477045856 | K050073 | 000 |