Cleared Special

Cathtong I PICC Catheter (K153469) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K153469 · L&Z Us, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
275d
Days
Class 2
Risk

K153469 is an FDA 510(k) clearance for the Cathtong I PICC Catheter. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by L&Z Us, Inc. (Fort Lee, US). The FDA issued a Cleared decision on September 1, 2016 after a review of 275 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all L&Z Us, Inc. devices

Submission Details

510(k) Number K153469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2015
Decision Date September 01, 2016
Days to Decision 275 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 129d · This submission: 275d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 90
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K153469.
PowerPICC Provena Catheters with SOLO Valve Technology
K162441 · C.R. Bard, Inc. · Apr 2017
PowerPICC Provena Catheters
K162443 · C.R. Bard, Inc. · Oct 2016
Turbo-Flo PICC Sets
K161496 · Cook Incorporated · Oct 2016
PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
K151985 · C.R. Bard, Inc. · Jun 2016
Sherlock 3CG Tip Positioning System Stylet
K142267 · C.R. Bard, Inc. · Oct 2014
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
K140345 · C.R. Bard, Inc. · Mar 2014