Submission Details
| 510(k) Number | K140080 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 14, 2014 |
| Decision Date | April 24, 2014 |
| Days to Decision | 100 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
Apr 2014
Decision
100d
Days
Class 2
Risk
About This 510(k) Submission
K140080 is an FDA 510(k) clearance for the ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB, 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 24, 2014, 100 days after receiving the submission on January 14, 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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