K982329 is an FDA 510(k) clearance for the VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900). This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Endosonics Corp. (Rancho Cordova,, US). The FDA issued a Cleared decision on January 14, 1999, 196 days after receiving the submission on July 2, 1998.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K982329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1998 |
| Decision Date | January 14, 1999 |
| Days to Decision | 196 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 |