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FDA 510(k)

STOCKERTIR PURGE CONTROL (APC) SYSTEM

K-Number: K041558 · 2004-07-02

ApplicantStockert Instrumente GmbH
Decision Date2004-07-02
Product CodeDTW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STOCKERTIR PURGE CONTROL (APC) SYSTEM 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 2004-07-02 under 510(k) number K041558. The device is classified under product code DTW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOCKERTIR PURGE CONTROL (APC) SYSTEM?

STOCKERTIR PURGE CONTROL (APC) SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-02. The listed applicant is Stockert Instrumente GmbH. The 510(k) number is K041558.

When did STOCKERTIR PURGE CONTROL (APC) SYSTEM receive FDA 510(k) clearance?

STOCKERTIR PURGE CONTROL (APC) SYSTEM received FDA 510(k) clearance on 2004-07-02, under 510(k) number K041558.

Who is the listed applicant for STOCKERTIR PURGE CONTROL (APC) SYSTEM?

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 STOCKERTIR PURGE CONTROL (APC) SYSTEM?

The FDA product code for STOCKERTIR PURGE CONTROL (APC) SYSTEM is DTW.

Related Clinical Trials

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.

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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 RHYTHMK032213STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMPK023622STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35K022280STOCKERT CORONARY PERFUSION CANNULAEK022321STOCKERT V172-28 VENOUS FEMORAL CANNULAK020571STOCKERT CENTRIFUGAL PUMP CONSOLE

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Related Devices (Code: DTW)

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.

K992857LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070Rocky Mountain Research, Inc.K955152STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMERStoeckert InstrumenteK910599CARDIOPULMONARY BYPASS LEVEL SENSING MONITORJtl Medical Corp.K924354STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITORSorin Biomedica, Fiat, USA, Inc.K915337CAPIOX LEVEL ALARMTerumo Medical Corp.K900910COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)Cobe Laboratories, 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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