The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Amplatz Support Wire Guide With Apex Curve.
| Device ID | K171445 |
| 510k Number | K171445 |
| Device Name: | Amplatz Support Wire Guide With Apex Curve |
| 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 | 2017-05-16 |
| Decision Date | 2018-01-10 |
| Summary: | summary |