K022238 is an FDA 510(k) clearance for the MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626. This device is classified as a Instruments, Surgical, Cardiovascular (Class I - General Controls, product code DWS).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 9, 2002, 90 days after receiving the submission on July 11, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4500.
| 510(k) Number | K022238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2002 |
| Decision Date | October 09, 2002 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWS — Instruments, Surgical, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4500 |