K041338 is an FDA 510(k) clearance for the MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES. This device is classified as a Stabilizer, Heart (Class I - General Controls, product code MWS).
Submitted by Medtronic Vascular (Brooklyn Park, US). The FDA issued a Cleared decision on July 19, 2004, 60 days after receiving the submission on May 20, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4500.
| 510(k) Number | K041338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2004 |
| Decision Date | July 19, 2004 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MWS — Stabilizer, Heart |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4500 |