The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Terumo Rocsafe Hybrid Perfusion System.
| Device ID | K082321 |
| 510k Number | K082321 |
| Device Name: | TERUMO ROCSAFE HYBRID PERFUSION SYSTEM |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Gary A Courtney |
| Correspondent | Gary A Courtney TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-13 |
| Decision Date | 2009-02-13 |
| Summary: | summary |