Cleared Traditional

THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (K101422) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101422 · Access Scientific, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 701
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K101422.
FieldFlex Steerable Sheath
K261492 · CenterPoint Systems, LLC · Jun 2026
Echo Large Bore Introducer Sheath
K260606 · Echo Medical, LLC · Apr 2026
Introducer Sheath Set
K254248 · Cardiocycle Medical(Suzhou) Co., Ltd. · Apr 2026
Edwards eSheath+ introducer set
K254279 · Edwards Lifesciences · Apr 2026
Aventus Introducer Sheath
K260091 · Inquis Medical · Apr 2026
Protaryx Transseptal Puncture Device (PTX2-001)
K260839 · Protaryx Medical, Inc. · Apr 2026