Cleared Traditional

Stiletto Extended Dwell Catheter

K210047 · Piper Access, LLC · General Hospital

Aug 2021

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K210047 is an FDA 510(k) clearance for the Stiletto Extended Dwell Catheter, a Midline Catheter (Class II — Special Controls, product code PND), submitted by Piper Access, LLC (Salt Lake City, US). The FDA issued a Cleared decision on August 27, 2021, 231 days after receiving the submission on January 8, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K210047 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 08, 2021
Decision Date	August 27, 2021
Days to Decision	231 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PND — Midline Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200
Definition	The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.