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FDA 510(k)

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology

K-Number: K181563 · 2018-09-26

ApplicantAccess Scientific, LLC
Decision Date2018-09-26
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology is the device name listed in this FDA 510(k) record. The listed applicant is Access Scientific, LLC. It received FDA 510(k) clearance on 2018-09-26 under 510(k) number K181563. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology?

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Access Scientific, LLC. The 510(k) number is K181563.

When did The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology receive FDA 510(k) clearance?

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology received FDA 510(k) clearance on 2018-09-26, under 510(k) number K181563.

Who is the listed applicant for The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology?

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

What is the FDA product code for The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology?

The FDA product code for The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology is DQY.

Related Clinical Trials

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Other records listing Access Scientific, LLC 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.

K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr ModelK182243The CVC WAND Safety Introducer with Valved Peelable SheathK162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model

Related Devices (Code: DQY)

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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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