The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Capiox Sp Pump (with Or Without X-coating).
Device ID | K080774 |
510k Number | K080774 |
Device Name: | CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) |
Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
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 | KFM |
CFR Regulation Number | 870.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2008-03-19 |
Decision Date | 2008-04-17 |
Summary: | summary |