Cleared Special

K121941 - ARROW PICC POWERED BY ARROW VPS STYLET

K121941 is an FDA 510(k) clearance for ARROW PICC POWERED BY ARROW VPS STYLET, manufactured by Arrow International (Subsidiary of Teleflex Inc.). The device is a Class 2 General Hospital device with product code LJS cleared through the Special 510(k) pathway after a 67-day FDA review.

K121941 · Arrow International (Subsidiary of Teleflex Inc.) · General Hospital
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Sep 2012
Decision
67d
Days
Class 2
Risk

K121941 is an FDA 510(k) clearance for the ARROW PICC POWERED BY ARROW VPS STYLET. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Arrow International (Subsidiary of Teleflex Inc.) (Reading, US). The FDA issued a Cleared decision on September 7, 2012 after a review of 67 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.

View all Arrow International (Subsidiary of Teleflex Inc.) devices

FDA 510(k) Submission Details - K121941

510(k) Number K121941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2012
Decision Date September 07, 2012
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
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 209
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K121941.
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
K130876 · Arrow International, Inc. · Apr 2013
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K122423 · Medical Components, Inc. · Dec 2012
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K121990 · Navilyst Medical, Inc. · Aug 2012
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
K113277 · Arrow International, Inc. · Jun 2012