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FDA 510(k)

TRANSRADIAL ARTERY ACCESS DEVICES

K-Number: K112554 · 2011-11-18

ApplicantTeleflexmedical, Inc.
Decision Date2011-11-18
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSRADIAL ARTERY ACCESS DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2011-11-18 under 510(k) number K112554. 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 TRANSRADIAL ARTERY ACCESS DEVICES?

TRANSRADIAL ARTERY ACCESS DEVICES is a medical device that received FDA 510(k) clearance on 2011-11-18. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K112554.

When did TRANSRADIAL ARTERY ACCESS DEVICES receive FDA 510(k) clearance?

TRANSRADIAL ARTERY ACCESS DEVICES received FDA 510(k) clearance on 2011-11-18, under 510(k) number K112554.

Who is the listed applicant for TRANSRADIAL ARTERY ACCESS DEVICES?

The FDA 510(k) record lists Teleflexmedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSRADIAL ARTERY ACCESS DEVICES?

The FDA product code for TRANSRADIAL ARTERY ACCESS DEVICES is DYB.

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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

View on FDA Database →

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

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