K884318 is an FDA 510(k) clearance for the THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM. This device is classified as a Probe, Thermodilution (Class II - Special Controls, product code KRB).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 13, 1988, 61 days after receiving the submission on October 13, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1915.
| 510(k) Number | K884318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 1988 |
| Decision Date | December 13, 1988 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KRB — Probe, Thermodilution |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1915 |