The following data is part of a premarket notification filed by Curative Medical Inc. with the FDA for Navajo Pta Balloon Dilatation Catheter.
| Device ID | K141354 |
| 510k Number | K141354 |
| Device Name: | NAVAJO PTA BALLOON DILATATION CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | CURATIVE MEDICAL INC. 1591 DEEPHAVEN DR Woodbury, MN 55129 |
| Contact | Bill Jacqmein |
| Correspondent | Bill Jacqmein CURATIVE MEDICAL INC. 1591 DEEPHAVEN DR Woodbury, MN 55129 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-23 |
| Decision Date | 2015-01-30 |
| Summary: | summary |