FDA 510(k)

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS

K-Number: K153487 · 2016-02-04

ApplicantArrow International, Inc. (Subsidiary of Teleflex, Inc.)

Decision Date2016-02-04

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2016-02-04 under 510(k) number K153487. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS?

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K153487.

When did CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS receive FDA 510(k) clearance?

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS received FDA 510(k) clearance on 2016-02-04, under 510(k) number K153487.

Who is the listed applicant for CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS?

The FDA 510(k) record lists Arrow International, Inc. (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 PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS?

The FDA product code for CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS is LJS.

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

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Related Devices (Code: LJS)

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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.