Cleared Traditional

K091954 - MICRO-STICK SET

K091954 is an FDA 510(k) clearance for MICRO-STICK SET, manufactured by Medcomp. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K091954 · Medcomp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
191d
Days
Class 2
Risk

K091954 is an FDA 510(k) clearance for the MICRO-STICK SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on January 8, 2010 after a review of 191 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K091954

510(k) Number K091954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date January 08, 2010
Days to Decision 191 days
Submission Type Traditional
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
66d slower than avg
Panel avg: 125d · This submission: 191d
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 673
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K091954.
ITG VASCULAR ACCESS SYSTEM, MODEL 300
K091006 · Arstasis, Inc. · Feb 2010
FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER
K093026 · Footprint Medical · Feb 2010
THE PICC WAND PEELABLE SAFETY INTRODUCER
K093022 · Access Scientific, Inc. · Jan 2010
GDS-DCS
K091367 · Guided Delivery Systems · Nov 2009
ENGAGE TR INTRODUCER
K093130 · St Jude Medical · Nov 2009
PTFE PEELABLE INTRODUCER
K093023 · Great Batch Medical · Oct 2009
K091954 · MICRO-STICK SET
Download PDF FDA Summary Medcomp