Cleared Special

K101150 - PICC WAND PEELABLE SAFETY INTRODUCER

K101150 is an FDA 510(k) clearance for PICC WAND PEELABLE SAFETY INTRODUCER, 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 112-day FDA review.

K101150 · Access Scientific, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
112d
Days
Class 2
Risk

K101150 is an FDA 510(k) clearance for the PICC WAND PEELABLE SAFETY INTRODUCER. 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 August 13, 2010 after a review of 112 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. 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. Standard predicate reliance. 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 - K101150

510(k) Number K101150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2010
Decision Date August 13, 2010
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
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 K101150.
VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V
K101604 · Vascular Solutions, Inc. · Jan 2011
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K101497 · Oscor, Inc. · Oct 2010
6F ENGAGE/ENGAGE TR INTRODUCER
K101883 · St Jude Medical · Sep 2010
GLIDESHEATH
K102008 · Terumo Medical Corp. · Jul 2010
RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
K093877 · Edwards Lifesciences, LLC · Jul 2010
GORE DRYSEAL SHEATH
K093791 · W.L. Gore & Associates, Inc. · Mar 2010