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FDA 510(k)

STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05

K-Number: K103469 · 2011-01-18

ApplicantSorin Group Deutschland GmbH
Decision Date2011-01-18
Product CodeKRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Deutschland GmbH. It received FDA 510(k) clearance on 2011-01-18 under 510(k) number K103469. The device is classified under product code KRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05?

STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 is a medical device that received FDA 510(k) clearance on 2011-01-18. The listed applicant is Sorin Group Deutschland GmbH. The 510(k) number is K103469.

When did STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 receive FDA 510(k) clearance?

STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 received FDA 510(k) clearance on 2011-01-18, under 510(k) number K103469.

Who is the listed applicant for STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05?

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

What is the FDA product code for STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05?

The FDA product code for STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 is KRL.

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Other records listing Sorin Group Deutschland 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.

K170460Sorin ConnectK131816SORIN CONNECT DATA MANAGEMENT SYSTEMK112225SORIN CENTRIFUGAL PUMP 5 (CP5)K103762SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLEK103468STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)K103168B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)

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Related Devices (Code: KRL)

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.

K090698CAPIOX BUBBLE TRAP WITH X-COATINGTerumo Cardiovascular SystemsK071231EDAC QUANTIFIERLuna Innovations, Inc.K961364AUTOMATIC TUBING CLAMP SYSTEM (ATC)Rocky Mountain Research, Inc.K961598ELS AUTOMATIC TUBING CLAMP SYSTEMRocky Mountain Research, Inc.K940651SARNS ULTRASONIC AIR SENSOR3M Health Care, SarnsK935977SARNS AIR DETECTION SYSTEM3M Health Care, Sarns

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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