Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter

Catheter, Percutaneous

SPECTRANETICS, INC.

The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Quick-cross Extreme Support Catheter, Quick-cross Select Support Catheter.

Pre-market Notification Details

Device IDK150201
510k NumberK150201
Device Name:Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
ClassificationCatheter, Percutaneous
Applicant SPECTRANETICS, INC. 9965 Federal Drive Colorado Springs,  CO  80921
ContactChristine Godleski
CorrespondentPharoah Garma
SPECTRANETICS, INC. 9965 Federal Drive Colorado Springs,  CO  80921
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-29
Decision Date2015-02-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20813132029597 K150201 000
20813132029429 K150201 000
20813132029436 K150201 000
20813132029443 K150201 000
20813132029450 K150201 000
00813132029463 K150201 000
20813132029474 K150201 000
20813132029481 K150201 000
20813132029498 K150201 000
20813132029511 K150201 000
20813132029528 K150201 000
20813132029535 K150201 000
20813132029542 K150201 000
20813132029559 K150201 000
20813132029566 K150201 000
20813132029573 K150201 000
20813132029580 K150201 000
20813132029412 K150201 000

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