The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto Vizigo 8.5f Bi-directional Guiding Sheath.
| Device ID | K170997 |
| 510k Number | K170997 |
| Device Name: | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath |
| Classification | Introducer, Catheter |
| Applicant | Biosense Webster, Inc. 33 Technology Drive Irvine, CA 92618 |
| Contact | John Jimenez |
| Correspondent | John Jimenez Biosense Webster, Inc. 33 Technology Drive Irvine, CA 92618 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-03 |
| Decision Date | 2017-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835016277 | K170997 | 000 |
| 10846835016260 | K170997 | 000 |
| 10846835016253 | K170997 | 000 |