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FDA 510(k)

CENTRIFUGAL PUMP

K-Number: K011838 · 2002-02-05

ApplicantStockert Instrumente GmbH
Decision Date2002-02-05
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CENTRIFUGAL PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Stockert Instrumente GmbH. It received FDA 510(k) clearance on 2002-02-05 under 510(k) number K011838. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIFUGAL PUMP?

CENTRIFUGAL PUMP is a medical device that received FDA 510(k) clearance on 2002-02-05. The listed applicant is Stockert Instrumente GmbH. The 510(k) number is K011838.

When did CENTRIFUGAL PUMP receive FDA 510(k) clearance?

CENTRIFUGAL PUMP received FDA 510(k) clearance on 2002-02-05, under 510(k) number K011838.

Who is the listed applicant for CENTRIFUGAL PUMP?

The FDA 510(k) record lists Stockert Instrumente GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTRIFUGAL PUMP?

The FDA product code for CENTRIFUGAL PUMP is DWA.

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Other records listing Stockert Instrumente GmbH 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.

K042374STOCKERT SCP RHYTHMK041558STOCKERTIR PURGE CONTROL (APC) SYSTEMK032213STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMPK023622STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35K022280STOCKERT CORONARY PERFUSION CANNULAEK022321STOCKERT V172-28 VENOUS FEMORAL CANNULA

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Related Devices (Code: DWA)

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.

K232788INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd.K230698Anivia SG1000 Pump ConsoleApmtd, Inc.K221491Anivia SG1000 Pump ConsoleApmtd, Inc.K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical , Ltd.K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula KitAbbott (Formerly Thoratec Corporation)K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott)

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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