The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Imaging Catheters.
| Device ID | K012537 |
| 510k Number | K012537 |
| Device Name: | REPROCESSED IMAGING CATHETERS |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Patrick Fleischhacker |
| Correspondent | Patrick Fleischhacker STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | OWQ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-07 |
| Decision Date | 2002-10-11 |