K132730 is an FDA 510(k) clearance for the BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE. This device is classified as a Probe, Blood-flow, Extravascular (Class II — Special Controls, product code DPT).
Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 30, 2014, 269 days after receiving the submission on September 3, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2120.
| 510(k) Number | K132730 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2013 |
| Decision Date | May 30, 2014 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPT — Probe, Blood-flow, Extravascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2120 |