The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Envoy Guiding Catheter.
| Device ID | K140307 |
| 510k Number | K140307 |
| Device Name: | ENVOY GUIDING CATHETER |
| 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 | 2014-02-07 |
| Decision Date | 2014-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704075042 | K140307 | 000 |
| 10886704075028 | K140307 | 000 |
| 10886704075011 | K140307 | 000 |
| 10886704074991 | K140307 | 000 |
| 10886704074977 | K140307 | 000 |
| 10886704074953 | K140307 | 000 |
| 10886704074939 | K140307 | 000 |
| 10886704074908 | K140307 | 000 |
| 10886704074878 | K140307 | 000 |
| 10886704074854 | K140307 | 000 |
| 10886704075059 | K140307 | 000 |
| 10886704074823 | K140307 | 000 |
| 10886704074847 | K140307 | 000 |
| 10886704075035 | K140307 | 000 |
| 10886704075004 | K140307 | 000 |
| 10886704074984 | K140307 | 000 |
| 10886704074960 | K140307 | 000 |
| 10886704074946 | K140307 | 000 |
| 10886704074922 | K140307 | 000 |
| 10886704074915 | K140307 | 000 |
| 10886704074885 | K140307 | 000 |
| 10886704074861 | K140307 | 000 |
| 10886704074830 | K140307 | 000 |