K042445 is an FDA 510(k) clearance for the SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 19, 2004, 40 days after receiving the submission on September 9, 2004.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K042445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2004 |
| Decision Date | October 19, 2004 |
| Days to Decision | 40 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 |