The following data is part of a premarket notification filed by Xablecath, Inc. with the FDA for Xablecath Support Catheter Product Family.
| Device ID | K180986 |
| 510k Number | K180986 |
| Device Name: | XableCath Support Catheter Product Family |
| Classification | Catheter, Percutaneous |
| Applicant | XableCath, Inc. 417 South Wakara Way, Suite 3510 Salt Lake City, UT 84108 -1457 |
| Contact | Rick Gaykowski |
| Correspondent | Rick Gaykowski XableCath, Inc. 417 South Wakara Way, Suite 3510 Salt Lake City, UT 84108 -1457 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-16 |
| Decision Date | 2018-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853989006071 | K180986 | 000 |
| 00853989006064 | K180986 | 000 |
| 00853989006057 | K180986 | 000 |
| 00853989006040 | K180986 | 000 |
| 00853989006033 | K180986 | 000 |
| 00853989006026 | K180986 | 000 |
| 00853989006019 | K180986 | 000 |
| 00853989006002 | K180986 | 000 |