K921091 is an FDA 510(k) clearance for the CHOLANGIOLAPCATH(TM). This device is classified as a Catheter, Cholangiography (Class I - General Controls, product code GBZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 6, 1992, 61 days after receiving the submission on March 6, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K921091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1992 |
| Decision Date | May 06, 1992 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GBZ — Catheter, Cholangiography |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |