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FDA 510(k)

CSS-CARDIOPLEGIA SAFETY SYSTEM

K-Number: K973237 · 1998-04-27

ApplicantMedtronic Bio-Medicus, Inc.
Decision Date1998-04-27
Product CodeDWB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CSS-CARDIOPLEGIA SAFETY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Bio-Medicus, Inc.. It received FDA 510(k) clearance on 1998-04-27 under 510(k) number K973237. 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 CSS-CARDIOPLEGIA SAFETY SYSTEM?

CSS-CARDIOPLEGIA SAFETY SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-27. The listed applicant is Medtronic Bio-Medicus, Inc.. The 510(k) number is K973237.

When did CSS-CARDIOPLEGIA SAFETY SYSTEM receive FDA 510(k) clearance?

CSS-CARDIOPLEGIA SAFETY SYSTEM received FDA 510(k) clearance on 1998-04-27, under 510(k) number K973237.

Who is the listed applicant for CSS-CARDIOPLEGIA SAFETY SYSTEM?

The FDA 510(k) record lists Medtronic Bio-Medicus, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CSS-CARDIOPLEGIA SAFETY SYSTEM?

The FDA product code for CSS-CARDIOPLEGIA SAFETY SYSTEM is DWB.

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Other records listing Medtronic Bio-Medicus, Inc. as applicant

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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.K972321S3 MAST PUMPStoeckert InstrumenteK971520S3 CYCLIC RPM CONTROLStoeckert InstrumenteK960974COBE 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.

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