K961147 is an FDA 510(k) clearance for the CLOSED FLUID COLLECTION SYSTEM. This device is classified as a Catheter, Irrigation (Class I - General Controls, product code GBX).
Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on May 31, 1996, 71 days after receiving the submission on March 21, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K961147 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1996 |
| Decision Date | May 31, 1996 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GBX — Catheter, Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |