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 | K052791 |
| 510k Number | K052791 |
| 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 | Stephanie Robinson |
| Correspondent | Stephanie Robinson 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 | 2005-10-03 |
| Decision Date | 2005-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033477050669 | K052791 | 000 |
| 08033477046105 | K052791 | 000 |
| 08033477046068 | K052791 | 000 |
| 08033477046044 | K052791 | 000 |
| 08033477046020 | K052791 | 000 |
| 08033477045986 | K052791 | 000 |
| 08033477045962 | K052791 | 000 |
| 08033477045948 | K052791 | 000 |
| 08033477045900 | K052791 | 000 |
| 08033477045887 | K052791 | 000 |
| 08033477045863 | K052791 | 000 |
| 08033477045825 | K052791 | 000 |
| 08033477045801 | K052791 | 000 |
| 08033477045788 | K052791 | 000 |
| 08033477045764 | K052791 | 000 |
| 08033477046129 | K052791 | 000 |
| 08033477046143 | K052791 | 000 |
| 08033477050287 | K052791 | 000 |
| 08033477050645 | K052791 | 000 |
| 08033477050621 | K052791 | 000 |
| 08033477050584 | K052791 | 000 |
| 08033477050560 | K052791 | 000 |
| 08033477050546 | K052791 | 000 |
| 08033477050508 | K052791 | 000 |
| 08033477050485 | K052791 | 000 |
| 08033477050461 | K052791 | 000 |
| 08033477050423 | K052791 | 000 |
| 08033477050409 | K052791 | 000 |
| 08033477050386 | K052791 | 000 |
| 08033477050348 | K052791 | 000 |
| 08033477050324 | K052791 | 000 |
| 08033477050300 | K052791 | 000 |
| 08033477045665 | K052791 | 000 |