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FDA 510(k)

SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS

K-Number: K810079 · 1981-01-30

Applicant3M Health Care, Sarns
Decision Date1981-01-30
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS is the device name listed in this FDA 510(k) record. The listed applicant is 3M Health Care, Sarns. It received FDA 510(k) clearance on 1981-01-30 under 510(k) number K810079. The device is classified under product code KRI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS?

SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS is a medical device that received FDA 510(k) clearance on 1981-01-30. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K810079.

When did SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS receive FDA 510(k) clearance?

SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS received FDA 510(k) clearance on 1981-01-30, under 510(k) number K810079.

Who is the listed applicant for SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS?

The FDA 510(k) record lists 3M Health Care, Sarns as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS?

The FDA product code for SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS is KRI.

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Other records listing 3M Health Care, Sarns 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.

K960916SAMS 8000 CARDIOPLEGIA MONITORK953901SARNS 800 ROLLER PUMPK9507393M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEMK941653SARNS TURBO MEMBRANE OXYGENATOR MODIFICATIONK941654SARNS FILTERED VENOUS RESERVIOR MODIFICATIONK940651SARNS ULTRASONIC AIR SENSOR

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Related Devices (Code: KRI)

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.

K0203653TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE3t Medical Systems, LLCK992635INTERFACE MODULE IDDDStoeckert InstrumenteK990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTSStoeckert InstrumenteK934782AMMEX TUBING ORGANIZERAmmex Cardiopulmonary Corp.K926233CARDIO2 CYCLEErgometrix, Inc.K922404TUBE GRIPGeorgia Medical Products, 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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