K833836 is an FDA 510(k) clearance for the IL HEPARINIZED FLOW DIRECTED THERMAL. This device is classified as a Catheter, Flow Directed (Class II - Special Controls, product code DYG).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984, 81 days after receiving the submission on November 15, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K833836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1983 |
| Decision Date | February 04, 1984 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DYG — Catheter, Flow Directed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1240 |