K073623 is an FDA 510(k) clearance for the ATLANTIS 018 PERIPHERAL IMAGING CATHETER. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Boston Scientific Corp (Fremont, US). The FDA issued a Cleared decision on March 13, 2008, 78 days after receiving the submission on December 26, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K073623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2007 |
| Decision Date | March 13, 2008 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | ITX — Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |