Cleared Special

K132133 - CG+ ARROW JACC POWERED BY ARROW VPS STYLET

K132133 is an FDA 510(k) clearance for CG+ ARROW JACC POWERED BY ARROW VPS STYLET, manufactured by Arrow International (Subsidiary of Teleflex Inc.). The device is a Class 2 Cardiovascular device with product code OBJ cleared through the Special 510(k) pathway after a 77-day FDA review.

K132133 · Arrow International (Subsidiary of Teleflex Inc.) · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
77d
Days
Class 2
Risk

K132133 is an FDA 510(k) clearance for the CG+ ARROW JACC POWERED BY ARROW VPS STYLET. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Arrow International (Subsidiary of Teleflex Inc.) (Reading, US). The FDA issued a Cleared decision on September 26, 2013 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight 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.

FDA 510(k) Submission Details - K132133

510(k) Number K132133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2013
Decision Date September 26, 2013
Days to Decision 77 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

OBJ Device Classification - Class 2, Special Controls

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - OBJ Catheter, Ultrasound, Intravascular

All 79
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K132133 · CG+ ARROW JACC POWERED BY ARROW VPS STYLET
Download PDF FDA Summary Arrow International (…