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FDA 510(k)

STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)

K-Number: K082344 · 2008-12-17

ApplicantSorin Group Deutschland GmbH
Decision Date2008-12-17
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) 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 2008-12-17 under 510(k) number K082344. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)?

STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) is a medical device that received FDA 510(k) clearance on 2008-12-17. The listed applicant is Sorin Group Deutschland GmbH. The 510(k) number is K082344.

When did STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) receive FDA 510(k) clearance?

STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) received FDA 510(k) clearance on 2008-12-17, under 510(k) number K082344.

Who is the listed applicant for STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)?

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 S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)?

The FDA product code for STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) is DWF.

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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)K103469STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05

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Related Devices (Code: DWF)

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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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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