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FDA 510(k)

CARDIOPLEGIA RECIRCULATION SYS-BL 705/A

K-Number: K831458 · 1983-10-20

ApplicantElectromedics, Inc.
Decision Date1983-10-20
Product CodeDWB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPLEGIA RECIRCULATION SYS-BL 705/A is the device name listed in this FDA 510(k) record. The listed applicant is Electromedics, Inc.. It received FDA 510(k) clearance on 1983-10-20 under 510(k) number K831458. 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 CARDIOPLEGIA RECIRCULATION SYS-BL 705/A?

CARDIOPLEGIA RECIRCULATION SYS-BL 705/A is a medical device that received FDA 510(k) clearance on 1983-10-20. The listed applicant is Electromedics, Inc.. The 510(k) number is K831458.

When did CARDIOPLEGIA RECIRCULATION SYS-BL 705/A receive FDA 510(k) clearance?

CARDIOPLEGIA RECIRCULATION SYS-BL 705/A received FDA 510(k) clearance on 1983-10-20, under 510(k) number K831458.

Who is the listed applicant for CARDIOPLEGIA RECIRCULATION SYS-BL 705/A?

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

What is the FDA product code for CARDIOPLEGIA RECIRCULATION SYS-BL 705/A?

The FDA product code for CARDIOPLEGIA RECIRCULATION SYS-BL 705/A is DWB.

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Other records listing Electromedics, 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.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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