Cleared Special

K153469 - Cathtong I PICC Catheter

K153469 is an FDA 510(k) clearance for Cathtong I PICC Catheter, manufactured by L&Z Us, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Special 510(k) pathway after a 275-day FDA review.

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

FDA 510(k) Submission Details - K153469

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.

LJS Device Classification - Class 2, Special Controls

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 194
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K153469.
PICC Maximal Barrier Nursing Kit
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K162443 · C.R. Bard, Inc. · Oct 2016
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Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
K152409 · Navilyst Medical, Inc. · Sep 2015
Xcela Power Injectable PICC
K150527 · Navilyst Medical, Inc. · Mar 2015