Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AXERA 2 ACCESS SYSTEM MODEL AXE200

K-Number: K123135 · 2013-01-28

ApplicantArstasis, Inc.
Decision Date2013-01-28
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AXERA 2 ACCESS SYSTEM MODEL AXE200 is the device name listed in this FDA 510(k) record. The listed applicant is Arstasis, Inc.. It received FDA 510(k) clearance on 2013-01-28 under 510(k) number K123135. 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 MODEL AXE200?

AXERA 2 ACCESS SYSTEM MODEL AXE200 is a medical device that received FDA 510(k) clearance on 2013-01-28. The listed applicant is Arstasis, Inc.. The 510(k) number is K123135.

When did AXERA 2 ACCESS SYSTEM MODEL AXE200 receive FDA 510(k) clearance?

AXERA 2 ACCESS SYSTEM MODEL AXE200 received FDA 510(k) clearance on 2013-01-28, under 510(k) number K123135.

Who is the listed applicant for AXERA 2 ACCESS SYSTEM MODEL AXE200?

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 MODEL AXE200?

The FDA product code for AXERA 2 ACCESS SYSTEM MODEL AXE200 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK121521AXERA ACCESS SYSTEMK113110AXERA ACCESS SYSTEMK103421ARSTASIS DILATOR ADAPTERK103143ARSTASIS ONE LATCHWIRE ACCESS SYSTEM

View all 10 devices →

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.

↑