ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,


Device Classification Name

pump, blood, cardiopulmonary bypass, roller type

510(k) Number K112587
Device Name ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson rd.
ann arbor, 
MI 
48103

Applicant Contact rebecca andersen
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson rd.
ann arbor, 
MI 
48103

Correspodent Contact rebecca andersen
Regulation Number 870.4370
Classification Product Code
DWB  
Date Received 09/06/2011
Decision Date 12/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No