Cleared Traditional

K101422 - THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

K101422 is an FDA 510(k) clearance for THE POWER WAND SAFETY INTRODUCER WITH A..., manufactured by Access Scientific, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K101422 · Access Scientific, Inc. · Cardiovascular device
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Mar 2011
Decision
306d
Days
Class 2
Risk

K101422 is an FDA 510(k) clearance for the THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Access Scientific, Inc. (San Diego, US). The FDA issued a Cleared decision on March 22, 2011 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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, Inc. devices

FDA 510(k) Submission Details - K101422

510(k) Number K101422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2010
Decision Date March 22, 2011
Days to Decision 306 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
181d slower than avg
Panel avg: 125d · This submission: 306d
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 491
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