Cleared Traditional

K131148 - THE CVC WAND SAFETY INTRODUCER WITH VAL...

K131148 is the FDA 510(k) clearance for THE CVC WAND SAFETY INTRODUCER WITH VAL... by Access Scientific, LLC. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K131148 · Access Scientific, LLC · Cardiovascular device
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Sep 2013
Decision
134d
Days
Class 2
Risk

K131148 is an FDA 510(k) clearance for the THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH. 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 September 4, 2013 after a review of 134 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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, LLC devices

Submission Details

510(k) Number K131148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2013
Decision Date September 04, 2013
Days to Decision 134 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
9d slower than avg
Panel avg: 125d · This submission: 134d
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 391
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K131148.
HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
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K132030 · Medtronic, Inc. · Sep 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K132164 · Merit Medical Systems, Inc. · Sep 2013
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
K130687 · Medical Components, Inc. · Aug 2013
EDWARDS EMBOL-X INTRODUCER SHEATH
K123714 · Edwards Lifesciences, LLC · Jul 2013
VALVED TEARAWAY INTRODUCER GENERATION II
K124046 · Medical Components, Inc. · Jun 2013