Cleared Special

K163513 - Arrow Endurance Extended Dwell Peripheral Catheter System (FDA 510(k) Clearance)

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

K163513 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · General Hospital
Feb 2017
Decision
71d
Days
Class 2
Risk

K163513 is an FDA 510(k) clearance for the Arrow Endurance Extended Dwell Peripheral Catheter System. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (Reading, US). The FDA issued a Cleared decision on February 24, 2017 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 K163513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2016
Decision Date February 24, 2017
Days to Decision 71 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 169d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 18
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K163513.
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