K113335 is an FDA 510(k) clearance for the HEARTRAIL III GUIDING CATHETER. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Terumo Corporation (Shibuya-Ku, Tokyo, JP). The FDA issued a Cleared decision on July 16, 2012, 245 days after receiving the submission on November 14, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K113335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2011 |
| Decision Date | July 16, 2012 |
| Days to Decision | 245 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO - Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |