SCIMED SIDELINER

Wire, Guide, Catheter

SCIMED

The following data is part of a premarket notification filed by Scimed with the FDA for Scimed Sideliner.

Pre-market Notification Details

Device IDK922706
510k NumberK922706
Device Name:SCIMED SIDELINER
ClassificationWire, Guide, Catheter
Applicant SCIMED 6655 WEDGEWOOD RD. Maple Grove,  MN  55369 -7503
ContactMercedes P Bayani
CorrespondentMercedes P Bayani
SCIMED 6655 WEDGEWOOD RD. Maple Grove,  MN  55369 -7503
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-05
Decision Date1992-12-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10193489067040 K922706 000
20193489078029 K922706 000

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