The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Sarns Soft-flow Aortic Cannula.
| Device ID | K132451 |
| 510k Number | K132451 |
| Device Name: | SARNS SOFT-FLOW AORTIC 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 | 2013-08-06 |
| Decision Date | 2014-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854916006383 | K132451 | 000 |
| 10854916006109 | K132451 | 000 |
| 10854916006123 | K132451 | 000 |
| 10854916006147 | K132451 | 000 |
| 10854916006161 | K132451 | 000 |
| 10854916006185 | K132451 | 000 |
| 10854916006208 | K132451 | 000 |
| 10854916006222 | K132451 | 000 |
| 10854916006246 | K132451 | 000 |
| 10854916006260 | K132451 | 000 |
| 10854916006284 | K132451 | 000 |
| 10854916006307 | K132451 | 000 |
| 10854916006321 | K132451 | 000 |
| 10854916006345 | K132451 | 000 |
| 10854916006369 | K132451 | 000 |
| 20854916006397 | K132451 | 000 |