The following data is part of a premarket notification filed by Sterilmed Inc. (johnson And Johnson) with the FDA for Reprocessed Pentaray Nav Eco High-density Mapping Catheter.
| Device ID | K201806 |
| 510k Number | K201806 |
| Device Name: | Reprocessed PentaRay Nav Eco High-Density Mapping Catheter |
| Classification | Catheter, Intracardiac Mapping, High-density Array |
| Applicant | Sterilmed Inc. (Johnson And Johnson) 5010 Cheshire Parkway N, Suite 2 Plymouth, MN 55446 |
| Contact | Jan Flegeau |
| Correspondent | Jan Flegeau Sterilmed Inc. (Johnson And Johnson) 5010 Cheshire Parkway N, Suite 2 Plymouth, MN 55446 |
| Product Code | MTD |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-01 |
| Decision Date | 2021-06-23 |