FDA 510(k)

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

K-Number: K112587 · 2011-12-19

ApplicantTerumo Cardiovascular Systems Corp.

Decision Date2011-12-19

Product CodeDWB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corp.. It received FDA 510(k) clearance on 2011-12-19 under 510(k) number K112587. The device is classified under product code DWB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, is a medical device that received FDA 510(k) clearance on 2011-12-19. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K112587.

When did ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, receive FDA 510(k) clearance?

ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, received FDA 510(k) clearance on 2011-12-19, under 510(k) number K112587.

Who is the listed applicant for ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,?

The FDA product code for ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, is DWB.

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Related Devices (Code: DWB)

K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation K131618LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTTerumo Cardiovascular Systems Corporation K973237CSS-CARDIOPLEGIA SAFETY SYSTEMMedtronic Bio-Medicus, Inc.K972321S3 MAST PUMPStoeckert Instrumente K971520S3 CYCLIC RPM CONTROLStoeckert Instrumente K960974COBE CENTURY PERFUSION PUMPCobe Cardiovascular, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.