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FDA 510(k)

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model

K-Number: K183066 · 2019-07-25

ApplicantAccess Scientific, LLC
Decision Date2019-07-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model is a medical device manufactured by Access Scientific, LLC. It received FDA 510(k) clearance on 2019-07-25 under approval number K183066. 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 The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model?

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model is a medical device that received FDA 510(k) clearance on 2019-07-25. It is manufactured by Access Scientific, LLC. The 510(k) number is K183066.

When was The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model approved by the FDA?

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model received FDA 510(k) clearance on 2019-07-25, under approval number K183066.

What company makes The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model?

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model is manufactured by Access Scientific, LLC.

What is the FDA product code for The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model?

The FDA product code for The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model is DYB.

Related Clinical Trials

NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT06604884 NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING

Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 39862365 Ensuring Medical Device Safety: The Role of Standards Organizations and Regulatory Bodies. Journal of medical systems (2025) PMID: 38283256 Bayesian approach for design and analysis of medical device trials in the era of modern clinical studies. Medical review (2021) (2023) PMID: 38086727 [Introduction and Reflection on Novel Medical Device Regulatory Science Tool MDDT]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023)

Other Devices by Access Scientific, LLC

K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology K182243The CVC WAND Safety Introducer with Valved Peelable Sheath

Related Devices (Code: DYB)

K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC K162097InTRAkitMedtronic Vascular K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc. K153771TXM Guiding SheathTexasmedical Technologies, Inc. K162184Edwards eSheath Introducer SetEdward Lifesciences K153494HQS Introducer (Model 2064-HQS)Alseal

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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