Cleared Special

K153423 - CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC (FDA 510(k) Clearance)

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

K153423 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · General Hospital
Jan 2016
Decision
64d
Days
Class 2
Risk

K153423 is an FDA 510(k) clearance for the CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (Reading, US). The FDA issued a Cleared decision on January 28, 2016 after a review of 64 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K153423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2015
Decision Date January 28, 2016
Days to Decision 64 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 169d · This submission: 64d
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 8
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