The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Pentaray Nav High-density Mapping Catheter.
| Device ID | K120425 |
| 510k Number | K120425 |
| Device Name: | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER |
| Classification | Catheter, Intracardiac Mapping, High-density Array |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Wayne R Hohman |
| Correspondent | Wayne R Hohman BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | MTD |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-13 |
| Decision Date | 2012-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835009620 | K120425 | 000 |
| 10846835009613 | K120425 | 000 |
| 10846835009606 | K120425 | 000 |
| 10846835009590 | K120425 | 000 |
| 10846835009583 | K120425 | 000 |
| 10846835009576 | K120425 | 000 |