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FDA 510(k)

Stiletto Extended Dwell Catheter

K-Number: K210047 · 2021-08-27

ApplicantPiper Access, LLC
Decision Date2021-08-27
Product CodePND
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Stiletto Extended Dwell Catheter is a medical device manufactured by Piper Access, LLC. It received FDA 510(k) clearance on 2021-08-27 under approval number K210047. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stiletto Extended Dwell Catheter?

Stiletto Extended Dwell Catheter is a medical device that received FDA 510(k) clearance on 2021-08-27. It is manufactured by Piper Access, LLC. The 510(k) number is K210047.

When was Stiletto Extended Dwell Catheter approved by the FDA?

Stiletto Extended Dwell Catheter received FDA 510(k) clearance on 2021-08-27, under approval number K210047.

What company makes Stiletto Extended Dwell Catheter?

Stiletto Extended Dwell Catheter is manufactured by Piper Access, LLC.

What is the FDA product code for Stiletto Extended Dwell Catheter?

The FDA product code for Stiletto Extended Dwell Catheter is PND.

Related Clinical Trials

NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT05694793 Trial for Reliability of Urodynamics SysTem RECRUITING

Other Devices by Piper Access, LLC

K1819045 FR Dual Lumen Piper PICC K191976Piper GO-IO Intraosseous Infusion System

Related Devices (Code: PND)

K162900PowerMidline CatheterC.R. Bard, Inc. K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic TechnologyArrow International, Inc. (Subsidiary of Teleflex, Inc.) K153393PowerMidline CatheterC.R. Bard, Inc. K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.) K170770CT MidlineMedical Components, Inc. (dba MedComp) K170158PowerGlide ST Midline CatheterC.R. Bard, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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