K925742 is an FDA 510(k) clearance for the CLARUS CHOLANGIOGRAM CATHETER KIT, a Catheter, Cholangiography (Class I — General Controls, product code GBZ), submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 1, 1993, 200 days after receiving the submission on November 13, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K925742 FDA.gov |
| FDA Decision | Cleared SESK |
| Date Received | November 13, 1992 |
| Decision Date | June 01, 1993 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GBZ — Catheter, Cholangiography |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4200 |