SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS

Catheter, Angioplasty, Peripheral, Transluminal

CLEARSTREAM TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Clearstream Technologies, Ltd. with the FDA for Savvy Long And Sleek Peripheral Transluminal Angioplasty (pta) Catheters.

Pre-market Notification Details

Device IDK072947
510k NumberK072947
Device Name:SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant CLEARSTREAM TECHNOLOGIES, LTD. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin,  TX  78746
ContactIan P Gordon
CorrespondentIan P Gordon
CLEARSTREAM TECHNOLOGIES, LTD. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin,  TX  78746
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-18
Decision Date2008-02-08
Summary:summary

NIH GUDID Devices

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