HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)

Apparatus, Autotransfusion

HAEMONETICS CORP.

The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Haemonetics Cardiovascular Perioperative Autotransfusion System (cardiopat).

Pre-market Notification Details

Device IDK053000
510k NumberK053000
Device Name:HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
ClassificationApparatus, Autotransfusion
Applicant HAEMONETICS CORP. 400 WOOD ROAD Braintree,  MA  02184 -9114
ContactGabriel J Muraca
CorrespondentGabriel J Muraca
HAEMONETICS CORP. 400 WOOD ROAD Braintree,  MA  02184 -9114
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-25
Decision Date2005-11-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30812747017941 K053000 000
30812747017279 K053000 000
30812747016180 K053000 000

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