Cleared Special

K111417 - THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

K111417 is an FDA 510(k) clearance for THE POWERWAND SAFETY INTRODUCER WITH AN..., manufactured by Access Scientific, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 56-day FDA review.

K111417 · Access Scientific, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
56d
Days
Class 2
Risk

K111417 is an FDA 510(k) clearance for the THE POWERWAND (R) 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 July 15, 2011 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111417

510(k) Number K111417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2011
Decision Date July 15, 2011
Days to Decision 56 days
Submission Type Special
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
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

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 667
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K111417.
AXERA ACCESS SYSTEM
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K111138 · Access Scientific, Inc. · Jun 2011
ENGAGE/ENGAGE TR INTRODUCERS
K111092 · St Jude Medical · Jun 2011
K111417 · THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
Download PDF FDA Summary Access Scientific, In…