The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Viewflex™ Xtra Ice Catheter.
| Device ID | K190478 |
| 510k Number | K190478 |
| Device Name: | Reprocessed ViewFlex™ Xtra ICE Catheter |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | Sterilmed, Inc. 5010 Cheshire Pkwy N, Suite 2 Plymouth, MN 55446 |
| Contact | Jan Flegeau |
| Correspondent | Jan Flegeau Sterilmed, Inc. 5010 Cheshire Pkwy N, Suite 2 Plymouth, MN 55446 |
| Product Code | OWQ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-27 |
| Decision Date | 2019-11-14 |