K881893 is an FDA 510(k) clearance for the NUMED BALLOON THERMODILUTION CATHETER. This device is classified as a Probe, Thermodilution (Class II - Special Controls, product code KRB).
Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on September 6, 1988, 124 days after receiving the submission on May 5, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1915.
| 510(k) Number | K881893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 1988 |
| Decision Date | September 06, 1988 |
| Days to Decision | 124 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 |