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FDA 510(k)

AXERA ACCESS SYSTEM

K-Number: K113110 · 2011-11-09

ApplicantArstasis, Inc.
Decision Date2011-11-09
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AXERA ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arstasis, Inc.. It received FDA 510(k) clearance on 2011-11-09 under 510(k) number K113110. 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 AXERA ACCESS SYSTEM?

AXERA ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-09. The listed applicant is Arstasis, Inc.. The 510(k) number is K113110.

When did AXERA ACCESS SYSTEM receive FDA 510(k) clearance?

AXERA ACCESS SYSTEM received FDA 510(k) clearance on 2011-11-09, under 510(k) number K113110.

Who is the listed applicant for AXERA ACCESS SYSTEM?

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

What is the FDA product code for AXERA ACCESS SYSTEM?

The FDA product code for AXERA ACCESS SYSTEM is DYB.

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Other records listing Arstasis, 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.

K132263AXERA 2 ACCESS SYSTEMK123618AXERA 2 ACCESS SYSTEMK123135AXERA 2 ACCESS SYSTEM MODEL AXE200K121521AXERA ACCESS SYSTEMK103421ARSTASIS DILATOR ADAPTERK103143ARSTASIS ONE LATCHWIRE ACCESS SYSTEM

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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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