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FDA 510(k)

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model

K-Number: K162322 · 2016-11-17

ApplicantAccess Scientific, LLC
Decision Date2016-11-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model is a medical device manufactured by Access Scientific, LLC. It received FDA 510(k) clearance on 2016-11-17 under approval number K162322. 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, 3Fr. Model?

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by Access Scientific, LLC. The 510(k) number is K162322.

When was the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model approved by the FDA?

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model received FDA 510(k) clearance on 2016-11-17, under approval number K162322.

What company makes the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model?

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model is manufactured by Access Scientific, LLC.

What is the FDA product code for the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model?

The FDA product code for the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. 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 NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_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: 41216379 The safety and efficacy of extended use of an oral shape-shifting superabsorbent hydrogel capsule for weight loss: The ELECT extension study. Obesity pillars (2025)

Other Devices by Access Scientific, LLC

K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology 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: DYB)

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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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