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FDA 510(k)

SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT

K-Number: K915547 · 1993-09-09

Applicant3M Health Care, Sarns
Decision Date1993-09-09
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT 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 1993-09-09 under 510(k) number K915547. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT?

SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT is a medical device that received FDA 510(k) clearance on 1993-09-09. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K915547.

When did SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT receive FDA 510(k) clearance?

SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT received FDA 510(k) clearance on 1993-09-09, under 510(k) number K915547.

Who is the listed applicant for SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT?

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 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT?

The FDA product code for SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT is KFM.

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Other records listing 3M Health Care, Sarns as applicant

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Related Devices (Code: KFM)

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.

K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)Spectrum Medical S.R.L.K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L.K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)Qura S.R.LK232132LifeSPARC SystemCardiacassist, Inc.K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsQura S.R.LK200091Capiox iCP Centrifugal PumpTerumo Cardiovascular Systems Corporation

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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