The following data is part of a premarket notification filed by Xablecath, Inc. with the FDA for Xablecath Crossing Catheter.
| Device ID | K183357 |
| 510k Number | K183357 |
| Device Name: | XableCath Crossing Catheter |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | XableCath, Inc. 417 S. Wakara Way, Ste 3510 Salt Lake City, UT 84108 -1457 |
| Contact | Rick Gaykowski |
| Correspondent | Rick Gaykowski XableCath, Inc. 417 S. Wakara Way, Ste 3510 Salt Lake City, UT 84108 -1457 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-04 |
| Decision Date | 2019-01-21 |
| Summary: | summary |