The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Indy Otw Vascular Retriever.
| Device ID | K160593 |
| 510k Number | K160593 |
| Device Name: | Indy OTW Vascular Retriever |
| Classification | Device, Percutaneous Retrieval |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Chad Schulenburg |
| Correspondent | Chad Schulenburg COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | MMX |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-01 |
| Decision Date | 2016-09-02 |
| Summary: | summary |