K860121 is an FDA 510(k) clearance for the INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER. This device is classified as a Probe, Blood-flow, Extravascular (Class II - Special Controls, product code DPT).
Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on June 2, 1986, 140 days after receiving the submission on January 13, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2120.
| 510(k) Number | K860121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 1986 |
| Decision Date | June 02, 1986 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DPT — Probe, Blood-flow, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2120 |