The following data is part of a premarket notification filed by Invatec Innovative Technologies, S.r.l. with the FDA for Amphirion Deep 0.014 Otw Pta Balloon Catheter.
| Device ID | K042624 |
| 510k Number | K042624 |
| Device Name: | 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-27 |
| Decision Date | 2005-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033477050331 | K042624 | 000 |
| 08033477050317 | K042624 | 000 |
| 08033477050294 | K042624 | 000 |
| 08033477050270 | K042624 | 000 |
| 08033477045818 | K042624 | 000 |
| 08033477045795 | K042624 | 000 |
| 08033477045771 | K042624 | 000 |
| 08033477045757 | K042624 | 000 |
| 08033477045658 | K042624 | 000 |