K932188 is an FDA 510(k) clearance for the SAFESET RESERVOIR. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 25, 1993, 172 days after receiving the submission on May 6, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K932188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1993 |
| Decision Date | October 25, 1993 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |