The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Envoy Guiding Catheters.
| Device ID | K093184 |
| 510k Number | K093184 |
| Device Name: | ENVOY GUIDING CATHETERS |
| Classification | Catheter, Percutaneous |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Kathryn Larose |
| Correspondent | Kathryn Larose 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 | 2009-10-09 |
| Decision Date | 2009-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704031802 | K093184 | 000 |
| 10886704031628 | K093184 | 000 |
| 10886704031611 | K093184 | 000 |
| 10886704031604 | K093184 | 000 |
| 10886704031598 | K093184 | 000 |
| 10886704031581 | K093184 | 000 |
| 10886704031574 | K093184 | 000 |
| 10886704027980 | K093184 | 000 |
| 10886704027973 | K093184 | 000 |
| 10886704027966 | K093184 | 000 |
| 10886704027959 | K093184 | 000 |
| 10886704027942 | K093184 | 000 |
| 10886704027935 | K093184 | 000 |
| 10886704027928 | K093184 | 000 |
| 10886704027911 | K093184 | 000 |
| 10886704027904 | K093184 | 000 |
| 10886704031635 | K093184 | 000 |
| 10886704031642 | K093184 | 000 |
| 10886704031796 | K093184 | 000 |
| 10886704031789 | K093184 | 000 |
| 10886704031772 | K093184 | 000 |
| 10886704031765 | K093184 | 000 |
| 10886704031758 | K093184 | 000 |
| 10886704031741 | K093184 | 000 |
| 10886704031734 | K093184 | 000 |
| 10886704031727 | K093184 | 000 |
| 10886704031710 | K093184 | 000 |
| 10886704031703 | K093184 | 000 |
| 10886704031697 | K093184 | 000 |
| 10886704031680 | K093184 | 000 |
| 10886704031673 | K093184 | 000 |
| 10886704031666 | K093184 | 000 |
| 10886704031659 | K093184 | 000 |
| 10886704027898 | K093184 | 000 |