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 | K083919 |
| 510k Number | K083919 |
| Device Name: | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 3101 EMRICK BLVD SUITE 113 Bethlehem, PA 18020 |
| Contact | Steve Camp |
| Correspondent | Steve Camp INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 3101 EMRICK BLVD SUITE 113 Bethlehem, PA 18020 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-31 |
| Decision Date | 2009-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033477050683 | K083919 | 000 |
| 08033477045924 | K083919 | 000 |
| 08033477045917 | K083919 | 000 |
| 08033477045849 | K083919 | 000 |
| 08033477045832 | K083919 | 000 |
| 08033477045740 | K083919 | 000 |
| 08033477045733 | K083919 | 000 |
| 08033477045726 | K083919 | 000 |
| 08033477045719 | K083919 | 000 |
| 08033477045702 | K083919 | 000 |
| 08033477045696 | K083919 | 000 |
| 08033477045689 | K083919 | 000 |
| 08033477045993 | K083919 | 000 |
| 08033477046006 | K083919 | 000 |
| 08033477046075 | K083919 | 000 |
| 08033477050607 | K083919 | 000 |
| 08033477050522 | K083919 | 000 |
| 08033477050447 | K083919 | 000 |
| 08033477050362 | K083919 | 000 |
| 08033477050263 | K083919 | 000 |
| 08033477050249 | K083919 | 000 |
| 08033477050225 | K083919 | 000 |
| 08033477050201 | K083919 | 000 |
| 08033477046167 | K083919 | 000 |
| 08033477046150 | K083919 | 000 |
| 08033477046082 | K083919 | 000 |
| 08033477045672 | K083919 | 000 |