The following data is part of a premarket notification filed by Ev3 Inc. with the FDA for Evercross .035 Otw Pta Dilatation Catheter.
| Device ID | K082579 |
| 510k Number | K082579 |
| Device Name: | EVERCROSS .035 OTW PTA DILATATION CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | EV3 INC. 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920 |
| Contact | David Worrell |
| Correspondent | David Worrell EV3 INC. 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-05 |
| Decision Date | 2008-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684040027 | K082579 | 000 |
| 00821684039908 | K082579 | 000 |
| 00821684039441 | K082579 | 000 |