FDA 510(k)

SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X

K-Number: K020998 · 2002-04-04

ApplicantTerumo Cardiovascular Systems Corp.

Decision Date2002-04-04

Product CodeKFM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corp.. It received FDA 510(k) clearance on 2002-04-04 under 510(k) number K020998. 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 CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X?

SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X is a medical device that received FDA 510(k) clearance on 2002-04-04. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K020998.

When did SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X receive FDA 510(k) clearance?

SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X received FDA 510(k) clearance on 2002-04-04, under 510(k) number K020998.

Who is the listed applicant for SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X?

The FDA product code for SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X is KFM.

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Related Devices (Code: KFM)

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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.