The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Double Flexible Tip Wire Guides.
| Device ID | K171912 |
| 510k Number | K171912 |
| Device Name: | Double Flexible Tip Wire Guides |
| Classification | Wire, Guide, Catheter |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Contact | Jennifer Allman |
| Correspondent | Jennifer Allman Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-26 |
| Decision Date | 2018-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002076228 | K171912 | 000 |