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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 a medical device manufactured by Access Scientific, LLC. It received FDA 510(k) clearance on 2018-09-26 under approval 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. It is manufactured by Access Scientific, LLC. The 510(k) number is K181563.

When was The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology approved by the FDA?

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 approval number K181563.

What company makes 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 manufactured by Access Scientific, LLC.

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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Related PubMed Literature

PMID: 40837401 Mining and evaluation of security alert signals of neuroprotective agents based on the Jinan adverse event reporting system database: a retrospective study. Frontiers in pharmacology (2025) PMID: 40037580 "Frank Antagonism to Patterned Organization": Medical Technology, Professional Power, and the Development of US Medical Device Regulation, 1950-1976. Journal of the history of medicine and allied sciences (2025) PMID: 39862365 Ensuring Medical Device Safety: The Role of Standards Organizations and Regulatory Bodies. Journal of medical systems (2025)

Other Devices by Access Scientific, LLC

K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model K182243The CVC WAND Safety Introducer with Valved Peelable Sheath K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, 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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