The following data is part of a premarket notification filed by Biosense Webster with the FDA for Carto Ent System.
| Device ID | K161701 |
| 510k Number | K161701 |
| Device Name: | CARTO ENT System |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | BIOSENSE WEBSTER 3333 DIAMOND CANYON ROAD Diamond Bar, CA 91765 |
| Contact | Melissa C. Schultz |
| Correspondent | Melissa C. Schultz BIOSENSE WEBSTER 3333 DIAMOND CANYON ROAD Diamond Bar, CA 91765 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-20 |
| Decision Date | 2016-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835018639 | K161701 | 000 |
| 10846835017182 | K161701 | 000 |