STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION

Port & Catheter, Implanted, Subcutaneous, Intravascular

STRATO MEDICAL CORP.

The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Strato Life Port Ii Dual Lumen Port/modification.

Pre-market Notification Details

Device IDK905847
510k NumberK905847
Device Name:STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly,  MA  01915
ContactNancy C Hall
CorrespondentNancy C Hall
STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly,  MA  01915
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-27
Decision Date1991-04-05

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