The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Needle's Eye Snare Retrieval Set - 54cm.
| Device ID | K163353 |
| 510k Number | K163353 |
| Device Name: | Needle's Eye Snare Retrieval Set - 54cm |
| Classification | Catheter, Embolectomy |
| Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Contact | Thomas Kardos |
| Correspondent | Thomas Kardos Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-30 |
| Decision Date | 2017-07-11 |
| Summary: | summary |