K905614 is an FDA 510(k) clearance for the JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS. This device is classified as a Catheter, Irrigation (Class I - General Controls, product code GBX).
Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on March 20, 1991, 96 days after receiving the submission on December 14, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K905614 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1990 |
| Decision Date | March 20, 1991 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GBX — Catheter, Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |