The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Pentaray Nav Eco High-density Mapping Catheter.
| Device ID | K123837 |
| 510k Number | K123837 |
| Device Name: | PENTARAY NAV ECO 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-13 |
| Decision Date | 2013-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835012262 | K123837 | 000 |
| 10846835012255 | K123837 | 000 |
| 10846835012248 | K123837 | 000 |
| 10846835012231 | K123837 | 000 |
| 10846835012224 | K123837 | 000 |
| 10846835012217 | K123837 | 000 |