Cleared Traditional

K183066 - The POWERWAND Safety Introducer with an...

K183066 is the FDA 510(k) clearance for The POWERWAND Safety Introducer with an... by Access Scientific, LLC. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K183066 · Access Scientific, LLC · Cardiovascular device
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Jul 2019
Decision
262d
Days
Class 2
Risk

K183066 is an FDA 510(k) clearance for the The POWERWAND Safety Introducer with an Extended Dwell Catheter made of Chron.... 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 July 25, 2019 after a review of 262 days - an extended review cycle.

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

Submission Details

510(k) Number K183066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2018
Decision Date July 25, 2019
Days to Decision 262 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 125d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 390
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K183066.
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
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Epicardial Access System
K191546 · Baylis Medical Company, Inc. · Aug 2019
Steerable Introducer
K191190 · Freudenberg Medical, LLC · Aug 2019
FlexSeal Introducer Sheath with Hydrophilic Coating
K190628 · Freudenberg Medical Mis, Inc. · May 2019
VersaCross Transseptal Sheath
K183655 · Baylis Medical Company, Inc. · May 2019
D'Vill Introducer
K190974 · NuMED, Inc. · May 2019