Stiletto Extended Dwell Catheter

Midline Catheter

Piper Access, LLC

The following data is part of a premarket notification filed by Piper Access, Llc with the FDA for Stiletto Extended Dwell Catheter.

Pre-market Notification Details

Device IDK210047
510k NumberK210047
Device Name:Stiletto Extended Dwell Catheter
ClassificationMidline Catheter
Applicant Piper Access, LLC 6030 W. Harold Gatty Dr. Salt Lake City,  UT  84116
ContactJay Muse
CorrespondentJay Muse
Piper Access, LLC 6030 W. Harold Gatty Dr. Salt Lake City,  UT  84116
Product CodePND  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-08
Decision Date2021-08-27

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