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FDA 510(k)

BLOOD PUMP-MODE S10K

K-Number: K780410 · 1978-05-03

Applicant3M Health Care, Sarns
Decision Date1978-05-03
Product CodeFIR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BLOOD PUMP-MODE S10K 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 1978-05-03 under 510(k) number K780410. The device is classified under product code FIR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD PUMP-MODE S10K?

BLOOD PUMP-MODE S10K is a medical device that received FDA 510(k) clearance on 1978-05-03. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K780410.

When did BLOOD PUMP-MODE S10K receive FDA 510(k) clearance?

BLOOD PUMP-MODE S10K received FDA 510(k) clearance on 1978-05-03, under 510(k) number K780410.

Who is the listed applicant for BLOOD PUMP-MODE S10K?

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 BLOOD PUMP-MODE S10K?

The FDA product code for BLOOD PUMP-MODE S10K is FIR.

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Other records listing 3M Health Care, Sarns as applicant

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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: FIR)

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.

K961137ATI PLASMA PUMP (PP-04)Apheresis Technologies, Inc.K831953INFUSION PUMPCryosan, Inc.K830818ASAHI BLOOD/PLASMA PUMP #ABP-01A &Parker Hannifin Corp.K821139SPS-SINGLE PATIENT SYSTEMExtracorporeal Medical Specialities, Inc.K771705RS-7800 MINIPUMPRenal Systems, Inc.K761050HEPARIN PUMPDws, 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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