The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Equaflow Multivalve Infusion Catheter.
| Device ID | K123235 |
| 510k Number | K123235 |
| Device Name: | EQUAFLOW MULTIVALVE INFUSION CATHETER |
| Classification | Introducer, Catheter |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Amber Brown |
| Correspondent | Amber Brown COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-16 |
| Decision Date | 2013-02-14 |
| Summary: | summary |