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FDA 510(k)

AXERA 2 ACCESS SYSTEM

K-Number: K123618 · 2013-03-24

ApplicantArstasis, Inc.
Decision Date2013-03-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AXERA 2 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 2013-03-24 under 510(k) number K123618. 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 2 ACCESS SYSTEM?

AXERA 2 ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-24. The listed applicant is Arstasis, Inc.. The 510(k) number is K123618.

When did AXERA 2 ACCESS SYSTEM receive FDA 510(k) clearance?

AXERA 2 ACCESS SYSTEM received FDA 510(k) clearance on 2013-03-24, under 510(k) number K123618.

Who is the listed applicant for AXERA 2 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 2 ACCESS SYSTEM?

The FDA product code for AXERA 2 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 SYSTEMK123135AXERA 2 ACCESS SYSTEM MODEL AXE200K121521AXERA ACCESS SYSTEMK113110AXERA 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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