K043453 is an FDA 510(k) clearance for the STERILEMED REPROCESSED IVUS IMAGING CATHETER. This device is classified as a Reprocessed Intravascular Ultrasound Catheter (Class II - Special Controls, product code OWQ).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on March 1, 2005, 76 days after receiving the submission on December 15, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200. For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology..
| 510(k) Number | K043453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2004 |
| Decision Date | March 01, 2005 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | OWQ — Reprocessed Intravascular Ultrasound Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
| Definition | For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology. |