SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS

Catheter, Percutaneous

SCIMED LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed 8 Fr. Triguideflex Guiding Catheters.

Pre-market Notification Details

Device IDK913830
510k NumberK913830
Device Name:SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS
ClassificationCatheter, Percutaneous
Applicant SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove,  MN  55369
ContactMercedes P Bayani
CorrespondentMercedes P Bayani
SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove,  MN  55369
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-26
Decision Date1991-11-22

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