The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Sarns High Flow Aortic Arch Cannula.
| Device ID | K133151 |
| 510k Number | K133151 |
| Device Name: | SARNS HIGH FLOW AORTIC ARCH CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Garry A Courtney |
| Correspondent | Garry A Courtney TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-02-03 |
| Summary: | summary |