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FDA 510(k)

SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF

K-Number: K912604 · 1991-10-28

ApplicantAries Medical, Inc.
Decision Date1991-10-28
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF is the device name listed in this FDA 510(k) record. The listed applicant is Aries Medical, Inc.. It received FDA 510(k) clearance on 1991-10-28 under 510(k) number K912604. 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 SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF?

SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF is a medical device that received FDA 510(k) clearance on 1991-10-28. The listed applicant is Aries Medical, Inc.. The 510(k) number is K912604.

When did SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF receive FDA 510(k) clearance?

SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF received FDA 510(k) clearance on 1991-10-28, under 510(k) number K912604.

Who is the listed applicant for SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF?

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

What is the FDA product code for SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF?

The FDA product code for SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF is KFM.

Related Clinical Trials

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Other records listing Aries Medical, Inc. 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.

K903925ARIES MELDICAL MODEL 2100HC HANK CRANKK903442ARIES TAPERSEAL(TM) SHEATHK895433ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYSK882289ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.K86499440CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETERK86453740CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER

View all 19 devices →

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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