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FDA 510(k)

SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM

K-Number: K092463 · 2009-11-05

ApplicantSorin Group Deutschland GmbH
Decision Date2009-11-05
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM 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 2009-11-05 under 510(k) number K092463. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM?

SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-05. The listed applicant is Sorin Group Deutschland GmbH. The 510(k) number is K092463.

When did SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM receive FDA 510(k) clearance?

SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM received FDA 510(k) clearance on 2009-11-05, under 510(k) number K092463.

Who is the listed applicant for SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM?

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 SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM?

The FDA product code for SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM is DTQ.

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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)K103468STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)K103762SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLEK103469STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05

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Related Devices (Code: DTQ)

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.

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbHK221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationK221373Essenz HLMLivanova Deutschland, GmbHK210130Stockert S5 SystemLivanova Deutschland, GmbHK202125Century Perfusion SystemCentury Hlm, LLCK190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical , Ltd.

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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