Cleared Traditional

K151513 - Arrow Endurance Extended Dwell Peripheral Catheter System

K151513 is an FDA 510(k) clearance for Arrow Endurance Extended Dwell Peripher..., manufactured by Arrow Internation, Inc. (Subsidiary of Teleflex Inc.). The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K151513 · Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
34d
Days
Class 2
Risk

K151513 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 Internation, Inc. (Subsidiary of Teleflex Inc.) (Reading, US). The FDA issued a Cleared decision on July 8, 2015 after a review of 34 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K151513

510(k) Number K151513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2015
Decision Date July 08, 2015
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FOZ Device Classification - Class 2, Special Controls

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 Consultant

Third Party Review Group, LLC
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The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 450
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K151513.
Arrow Endurance Extended Dwell Peripheral Catheter System
K152272 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Nov 2015
BD Angiocath IV Catheter, BD Insyte IV Catheter
K151698 · Becton Dickinson Infusion Therapy Systems, Inc. · Jul 2015
MedSource ClearSafe Safety IV Catheter
K150611 · Medsource International · Jul 2015
I.V. Catheter
K142797 · Jiangxi Sanxin Medtec Co., Ltd. · Jun 2015
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
K150109 · Arrow International (A Subsidiary of Teleflex, Inc.) · Jun 2015
BioFlo Midline Catheter
K150407 · Navilyst Medical, Inc. · May 2015

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.