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FDA 510(k)

SARNS 800 ROLLER PUMP

K-Number: K953901 · 1996-04-19

Applicant3M Health Care, Sarns
Decision Date1996-04-19
Product CodeDWB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SARNS 800 ROLLER PUMP 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 1996-04-19 under 510(k) number K953901. 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 SARNS 800 ROLLER PUMP?

SARNS 800 ROLLER PUMP is a medical device that received FDA 510(k) clearance on 1996-04-19. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K953901.

When did SARNS 800 ROLLER PUMP receive FDA 510(k) clearance?

SARNS 800 ROLLER PUMP received FDA 510(k) clearance on 1996-04-19, under 510(k) number K953901.

Who is the listed applicant for SARNS 800 ROLLER PUMP?

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 800 ROLLER PUMP?

The FDA product code for SARNS 800 ROLLER PUMP is DWB.

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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 MONITORK9507393M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEMK941653SARNS TURBO MEMBRANE OXYGENATOR MODIFICATIONK941654SARNS FILTERED VENOUS RESERVIOR MODIFICATIONK940651SARNS ULTRASONIC AIR SENSORK935391SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK

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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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