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FDA 510(k)

ARSTASIS DILATOR ADAPTER

K-Number: K103421 · 2011-05-24

ApplicantArstasis, Inc.
Decision Date2011-05-24
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARSTASIS DILATOR ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Arstasis, Inc.. It received FDA 510(k) clearance on 2011-05-24 under 510(k) number K103421. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARSTASIS DILATOR ADAPTER?

ARSTASIS DILATOR ADAPTER is a medical device that received FDA 510(k) clearance on 2011-05-24. The listed applicant is Arstasis, Inc.. The 510(k) number is K103421.

When did ARSTASIS DILATOR ADAPTER receive FDA 510(k) clearance?

ARSTASIS DILATOR ADAPTER received FDA 510(k) clearance on 2011-05-24, under 510(k) number K103421.

Who is the listed applicant for ARSTASIS DILATOR ADAPTER?

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 ARSTASIS DILATOR ADAPTER?

The FDA product code for ARSTASIS DILATOR ADAPTER is DRE.

Related Clinical Trials

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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 SYSTEMK103143ARSTASIS ONE LATCHWIRE ACCESS SYSTEM

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Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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