Cleared Traditional

K162322 - the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model

K162322 is an FDA 510(k) clearance for the POWERWAND Safety Introducer with an..., manufactured by Access Scientific, LLC. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K162322 · Access Scientific, LLC · Cardiovascular device
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Nov 2016
Decision
90d
Days
Class 2
Risk

K162322 is an FDA 510(k) clearance for the the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Access Scientific, LLC (San Diego, US). The FDA issued a Cleared decision on November 17, 2016 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Access Scientific, LLC devices

FDA 510(k) Submission Details - K162322

510(k) Number K162322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2016
Decision Date November 17, 2016
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K162322.
FlexCath Select Steerable Shealth and Dilator
K163268 · Medtronic Cryocath, LP · Feb 2017
Vado Bi-Directional Steerable Sheath
K162427 · Kalila Medical, Inc. · Jan 2017
InTRAkit
K162097 · Medtronic Vascular · Nov 2016
Pinpoint GT Introducer Needle
K162769 · C.R. Bard, Inc. · Nov 2016
TXM Guiding Sheath
K153771 · Texasmedical Technologies, Inc. · Sep 2016
Edwards eSheath Introducer Set
K162184 · Edward Lifesciences · Sep 2016