FDA 510(k) Application Details - K210047

Device Classification Name	More FDA Info for this Device
510(K) Number	K210047
Device Name	Stiletto Extended Dwell Catheter
Applicant	Piper Access, LLC 6030 W. Harold Gatty Dr. Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Jay Muse Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PND Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/2021
Decision Date	08/27/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review