The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Envoy Distal Access Guiding Catheter.
| Device ID | K120229 |
| 510k Number | K120229 |
| Device Name: | ENVOY DISTAL ACCESS GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Catherine Kilshaw |
| Correspondent | Catherine Kilshaw Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-25 |
| Decision Date | 2012-02-24 |
| Summary: | summary |