Submission Details
| 510(k) Number | K140307 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 07, 2014 |
| Decision Date | April 21, 2014 |
| Days to Decision | 73 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
ENVOY GUIDING CATHETER
Apr 2014
Decision
73d
Days
Class 2
Risk
About This 510(k) Submission
K140307 is an FDA 510(k) clearance for the ENVOY GUIDING CATHETER, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on April 21, 2014, 73 days after receiving the submission on February 7, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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