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FDA 510(k)

ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER

K-Number: K122854 · 2013-01-04

ApplicantArrow International (Subsidiary of Teleflex Inc.)
Decision Date2013-01-04
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 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 2013-01-04 under 510(k) number K122854. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER?

ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER is a medical device that received FDA 510(k) clearance on 2013-01-04. The listed applicant is Arrow International (Subsidiary of Teleflex Inc.). The 510(k) number is K122854.

When did ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER receive FDA 510(k) clearance?

ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER received FDA 510(k) clearance on 2013-01-04, under 510(k) number K122854.

Who is the listed applicant for ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER?

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 ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER?

The FDA product code for ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER is DYB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132133CG+ ARROW JACC POWERED BY ARROW VPS STYLETK121501ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)K122545CG+ ARROW PICC POWERED BY ARROW VPS STYLETK121941ARROW PICC POWERED BY ARROW VPS STYLETK112896ARRW EVOLUTION

Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.

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