SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS

Catheter, Percutaneous

SPECTRANETICS CORP.

The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Spectranetics Quick-cross Extreme Support Catheters.

Pre-market Notification Details

Device IDK082561
510k NumberK082561
Device Name:SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS
ClassificationCatheter, Percutaneous
Applicant SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs,  CO  80907 -5159
ContactMichael K Handley
CorrespondentMichael K Handley
SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs,  CO  80907 -5159
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-04
Decision Date2008-12-10
Summary:summary

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