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FDA 510(k)

DIDECO PEDIATRIC ARTERIAL FILTERS

K-Number: K945198 · 1995-06-27

ApplicantSorin Biomedical, Inc.
Decision Date1995-06-27
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIDECO PEDIATRIC ARTERIAL FILTERS 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 1995-06-27 under 510(k) number K945198. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIDECO PEDIATRIC ARTERIAL FILTERS?

DIDECO PEDIATRIC ARTERIAL FILTERS is a medical device that received FDA 510(k) clearance on 1995-06-27. The listed applicant is Sorin Biomedical, Inc.. The 510(k) number is K945198.

When did DIDECO PEDIATRIC ARTERIAL FILTERS receive FDA 510(k) clearance?

DIDECO PEDIATRIC ARTERIAL FILTERS received FDA 510(k) clearance on 1995-06-27, under 510(k) number K945198.

Who is the listed applicant for DIDECO PEDIATRIC ARTERIAL FILTERS?

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 DIDECO PEDIATRIC ARTERIAL FILTERS?

The FDA product code for DIDECO PEDIATRIC ARTERIAL FILTERS is DTM.

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Other records listing Sorin Biomedical, Inc. 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.

K990103MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHEK963758CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINEK963759DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMSK964908VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTERK964907VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILTK961869DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40

View all 15 devices →

Related Devices (Code: DTM)

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.

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronicK242953KIDS Arterial FiltersSorin Group Italia S.R.L.K242092MICRO Arterial FiltersSorin Group Italia S.R.L.K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc.K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEMedtronic Perfusion SystemsK122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, 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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