Submission Details
| 510(k) Number | K120229 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 25, 2012 |
| Decision Date | February 24, 2012 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
ENVOY DISTAL ACCESS GUIDING CATHETER
Feb 2012
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K120229 is an FDA 510(k) clearance for the ENVOY DISTAL ACCESS 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 February 24, 2012, 30 days after receiving the submission on January 25, 2012. 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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