Cleared Traditional

K093026 - FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER

K093026 is an FDA 510(k) clearance for FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER, manufactured by Footprint Medical. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K093026 · Footprint Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
148d
Days
Class 2
Risk

K093026 is an FDA 510(k) clearance for the FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Footprint Medical (San Antonio, US). The FDA issued a Cleared decision on February 24, 2010 after a review of 148 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 Footprint Medical devices

FDA 510(k) Submission Details - K093026

510(k) Number K093026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2009
Decision Date February 24, 2010
Days to Decision 148 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 409
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K093026.
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
MICRO-STICK SET
K091954 · Medcomp · Jan 2010
ENGAGE TR INTRODUCER
K093130 · St Jude Medical · Nov 2009
ENGAGE/ENGAGE TR
K092575 · St Jude Medical · Oct 2009