The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Envoy Distal Access (da) Guiding Catheter, 6f, 95cm & 105cm, Straight & Xb, Mpd & Xb, Mpc & Xb.
| Device ID | K140080 |
| 510k Number | K140080 |
| Device Name: | ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB |
| Classification | Catheter, Percutaneous |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Hannah Foley |
| Correspondent | Hannah Foley 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 | 2014-01-14 |
| Decision Date | 2014-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704075127 | K140080 | 000 |
| 10878528000652 | K140080 | 000 |
| 10878528000669 | K140080 | 000 |
| 10878528000676 | K140080 | 000 |
| 10886704074816 | K140080 | 000 |
| 10886704075066 | K140080 | 000 |
| 10886704075073 | K140080 | 000 |
| 10886704075080 | K140080 | 000 |
| 10886704075097 | K140080 | 000 |
| 10886704075103 | K140080 | 000 |
| 10886704075110 | K140080 | 000 |
| 10878528000645 | K140080 | 000 |