Cleared Special

K121748 - THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL

K121748 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 43-day FDA review.

K121748 · Access Scientific, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
43d
Days
Class 2
Risk

K121748 is an FDA 510(k) clearance for the THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL. 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 27, 2012 after a review of 43 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.

View all Access Scientific, Inc. devices

FDA 510(k) Submission Details - K121748

510(k) Number K121748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2012
Decision Date July 27, 2012
Days to Decision 43 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
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 491
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K121748.
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