FDA 510(k)

SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS

K-Number: K936183 · 1994-03-23

Decision Date1994-03-23

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedical, Inc.. It received FDA 510(k) clearance on 1994-03-23 under 510(k) number K936183. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS?

SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS is a medical device that received FDA 510(k) clearance on 1994-03-23. The listed applicant is Sorin Biomedical, Inc.. The 510(k) number is K936183.

When did SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS receive FDA 510(k) clearance?

SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS received FDA 510(k) clearance on 1994-03-23, under 510(k) number K936183.

Who is the listed applicant for SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS?

The FDA 510(k) record lists Sorin Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS?

The FDA product code for SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS is DTN.

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Other records listing Sorin Biomedical, Inc. as applicant

K990103MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE K963759DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS K963758CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE K964908VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER K964907VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT K961869DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40

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Related Devices (Code: DTN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.