K183353 is an FDA 510(k) clearance for the Telescope Guide Extension Catheter. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Medtronic, Inc. (Galway, IE). The FDA issued a Cleared decision on March 22, 2019, 109 days after receiving the submission on December 3, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K183353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2018 |
| Decision Date | March 22, 2019 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |