The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Sarns Soft-flow Extended Aortic Cannula.
| Device ID | K132811 |
| 510k Number | K132811 |
| Device Name: | SARNS SOFT-FLOW EXTENDED AORTIC CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | Terumo Cardiovascular Systems Corporation 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Garry A Courtney |
| Correspondent | Garry A Courtney Terumo Cardiovascular Systems Corporation 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-09 |
| Decision Date | 2014-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854916006468 | K132811 | 000 |
| 20854916006458 | K132811 | 000 |
| 20854916006434 | K132811 | 000 |
| 20854916006410 | K132811 | 000 |