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FDA 510(k)

ITG VASCULAR ACCESS SYSTEM, MODEL 300

K-Number: K091006 · 2010-02-25

ApplicantArstasis, Inc.
Decision Date2010-02-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ITG VASCULAR ACCESS SYSTEM, MODEL 300 is the device name listed in this FDA 510(k) record. The listed applicant is Arstasis, Inc.. It received FDA 510(k) clearance on 2010-02-25 under 510(k) number K091006. 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 ITG VASCULAR ACCESS SYSTEM, MODEL 300?

ITG VASCULAR ACCESS SYSTEM, MODEL 300 is a medical device that received FDA 510(k) clearance on 2010-02-25. The listed applicant is Arstasis, Inc.. The 510(k) number is K091006.

When did ITG VASCULAR ACCESS SYSTEM, MODEL 300 receive FDA 510(k) clearance?

ITG VASCULAR ACCESS SYSTEM, MODEL 300 received FDA 510(k) clearance on 2010-02-25, under 510(k) number K091006.

Who is the listed applicant for ITG VASCULAR ACCESS SYSTEM, MODEL 300?

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 ITG VASCULAR ACCESS SYSTEM, MODEL 300?

The FDA product code for ITG VASCULAR ACCESS SYSTEM, MODEL 300 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 SYSTEMK113110AXERA ACCESS SYSTEMK103421ARSTASIS DILATOR ADAPTER

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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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