The following data is part of a premarket notification filed by Xablecath, Inc. with the FDA for Xablecath Support Catheter.
| Device ID | K170041 |
| 510k Number | K170041 |
| Device Name: | XableCath Support Catheter |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-05 |
| Decision Date | 2017-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853989006170 | K170041 | 000 |
| 00853989006163 | K170041 | 000 |
| 00853989006156 | K170041 | 000 |
| 00853989006149 | K170041 | 000 |
| 00853989006132 | K170041 | 000 |
| 00853989006125 | K170041 | 000 |
| 00853989006118 | K170041 | 000 |
| 00853989006101 | K170041 | 000 |
| 00853989006095 | K170041 | 000 |