K810661 is an FDA 510(k) clearance for the CATHDAMP. This device is classified as a Transducer, Blood-pressure, Extravascular (Class II - Special Controls, product code DRS).
Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 27, 1981, 16 days after receiving the submission on March 11, 1981.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2850.
| 510(k) Number | K810661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1981 |
| Decision Date | March 27, 1981 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRS — Transducer, Blood-pressure, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2850 |