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FDA 510(k)

COBE CENTURY PERFUSION PUMP

K-Number: K960974 · 1997-07-14

ApplicantCobe Cardiovascular, Inc.
Decision Date1997-07-14
Product CodeDWB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE CENTURY PERFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Cardiovascular, Inc.. It received FDA 510(k) clearance on 1997-07-14 under 510(k) number K960974. 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 COBE CENTURY PERFUSION PUMP?

COBE CENTURY PERFUSION PUMP is a medical device that received FDA 510(k) clearance on 1997-07-14. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K960974.

When did COBE CENTURY PERFUSION PUMP receive FDA 510(k) clearance?

COBE CENTURY PERFUSION PUMP received FDA 510(k) clearance on 1997-07-14, under 510(k) number K960974.

Who is the listed applicant for COBE CENTURY PERFUSION PUMP?

The FDA 510(k) record lists Cobe Cardiovascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBE CENTURY PERFUSION PUMP?

The FDA product code for COBE CENTURY PERFUSION PUMP is DWB.

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Other records listing Cobe Cardiovascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050111SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAGK042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMK040184DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTERK033641SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800K030462COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700K021830SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

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Related Devices (Code: DWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationK131618LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTTerumo Cardiovascular Systems CorporationK112587ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,Terumo Cardiovascular Systems Corp.K973237CSS-CARDIOPLEGIA SAFETY SYSTEMMedtronic Bio-Medicus, Inc.K972321S3 MAST PUMPStoeckert InstrumenteK971520S3 CYCLIC RPM CONTROLStoeckert Instrumente

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.

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