PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380

Set, Administration, Intravascular

MAERSK MEDICAL A/S

The following data is part of a premarket notification filed by Maersk Medical A/s with the FDA for Paradigm Silhouette, Models Mmt-377, 378, 379, 380.

Pre-market Notification Details

Device IDK002138
510k NumberK002138
Device Name:PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
ClassificationSet, Administration, Intravascular
Applicant MAERSK MEDICAL A/S 12744 SAN FERNANDO RD. Sylmar,  CA  91342
ContactJennifer Lyons
CorrespondentJennifer Lyons
MAERSK MEDICAL A/S 12744 SAN FERNANDO RD. Sylmar,  CA  91342
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-17
Decision Date2000-08-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05705244009332 K002138 000
05705244005235 K002138 000
05705244005259 K002138 000
05705244005273 K002138 000
05705244008410 K002138 000
05705244008434 K002138 000
05705244008564 K002138 000
05705244008588 K002138 000
05705244008731 K002138 000
05705244008755 K002138 000
05705244008878 K002138 000
05705244008892 K002138 000
05705244009011 K002138 000
05705244009035 K002138 000
05705244009141 K002138 000
05705244009165 K002138 000
05705244009318 K002138 000
05705244005211 K002138 000

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