Cleared Special

K131300 - THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

K131300 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 Special 510(k) pathway after a 31-day FDA review.

K131300 · Access Scientific, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
31d
Days
Class 2
Risk

K131300 is an FDA 510(k) clearance for the THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER. 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 June 7, 2013 after a review of 31 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 - K131300

510(k) Number K131300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2013
Decision Date June 07, 2013
Days to Decision 31 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
94d faster than avg
Panel avg: 125d · This submission: 31d
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 705
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K131300.
PTFE SUPER SHEATH INTRODUCER
K130855 · Martech Medical Products · Jul 2013
EDWARDS EMBOL-X INTRODUCER SHEATH
K123714 · Edwards Lifesciences, LLC · Jul 2013
CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER
K131332 · Cardiosolutions, Inc. · Jul 2013
VALVED TEARAWAY INTRODUCER GENERATION II
K124046 · Medical Components, Inc. · Jun 2013
MOBICATH BI-DIRECTIONAL GUIDING SHEATH
K130559 · Great Batch Medical · May 2013
SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
K121404 · Onset Medical Corporation · May 2013
K131300 · THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
Download PDF FDA Summary Access Scientific, LLC