K033436 is an FDA 510(k) clearance for the REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER. This device is classified as a Reprocessed Intravascular Ultrasound Catheter (Class II - Special Controls, product code OWQ).
Submitted by Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on March 16, 2005, 505 days after receiving the submission on October 28, 2003.
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 | K033436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2003 |
| Decision Date | March 16, 2005 |
| Days to Decision | 505 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. |