FDA 510(k)

CG+ ARROW JACC POWERED BY ARROW VPS STYLET

K-Number: K132133 · 2013-09-26

ApplicantArrow International (Subsidiary of Teleflex Inc.)

Decision Date2013-09-26

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CG+ ARROW JACC POWERED BY ARROW VPS STYLET is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International (Subsidiary of Teleflex Inc.). It received FDA 510(k) clearance on 2013-09-26 under 510(k) number K132133. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CG+ ARROW JACC POWERED BY ARROW VPS STYLET?

CG+ ARROW JACC POWERED BY ARROW VPS STYLET is a medical device that received FDA 510(k) clearance on 2013-09-26. The listed applicant is Arrow International (Subsidiary of Teleflex Inc.). The 510(k) number is K132133.

When did CG+ ARROW JACC POWERED BY ARROW VPS STYLET receive FDA 510(k) clearance?

CG+ ARROW JACC POWERED BY ARROW VPS STYLET received FDA 510(k) clearance on 2013-09-26, under 510(k) number K132133.

Who is the listed applicant for CG+ ARROW JACC POWERED BY ARROW VPS STYLET?

The FDA 510(k) record lists Arrow International (Subsidiary of Teleflex Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CG+ ARROW JACC POWERED BY ARROW VPS STYLET?

The FDA product code for CG+ ARROW JACC POWERED BY ARROW VPS STYLET is OBJ.

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Other records listing Arrow International (Subsidiary of Teleflex Inc.) as applicant

K122854ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER K121501ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)K122545CG+ ARROW PICC POWERED BY ARROW VPS STYLET K121941ARROW PICC POWERED BY ARROW VPS STYLET K112896ARRW EVOLUTION

Related Devices (Code: OBJ)

K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited K252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston Scientific K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device K250955XC11 ICE System, USAYorlabs, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.