The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Cook Turbo-flo Hd Acute Hemodialysis Catheter Set/tray Cook Spectrum Turbo-flo Hd Acute Hemodialysis Catheter Set/tray.
| Device ID | K122091 |
| 510k Number | K122091 |
| Device Name: | COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | COOK, INC. 750 DANIELS WAY Blmgtn, IN 47404 |
| Contact | Sean Spence |
| Correspondent | Sean Spence COOK, INC. 750 DANIELS WAY Blmgtn, IN 47404 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2013-07-29 |
| Summary: | summary |