Cleared Special

K071330 - GALTSTICK INTRODUCER SYSTEM

K071330 is the FDA 510(k) clearance for GALTSTICK INTRODUCER SYSTEM by Galt Medical Corp.. It is a Class 2 Cardiovascular device (product code DRE) cleared through the Special 510(k) pathway after a 173-day FDA review.

K071330 · Galt Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
173d
Days
Class 2
Risk

K071330 is an FDA 510(k) clearance for the GALTSTICK INTRODUCER SYSTEM. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on October 31, 2007 after a review of 173 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 Galt Medical Corp. devices

Submission Details

510(k) Number K071330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2007
Decision Date October 31, 2007
Days to Decision 173 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
48d slower than avg
Panel avg: 125d · This submission: 173d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 44
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K071330.
RETROFLEX DILATOR KIT
K093554 · Edwards Lifesciences, LLC · Apr 2010
MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
K091584 · Merit Medical Systems, Inc. · Oct 2009
PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
K073035 · Merit Medical Systems, Inc. · Nov 2007
PRELUDE SHEATH INTRODUCER
K070159 · Merit Medical Systems, Inc. · Jun 2007
MERIT PRELUDE SHEATH INTRODUCER
K050962 · Merit Medical Systems, Inc. · May 2005
MERIT MAK (MINI ACCESS KIT)
K031691 · Merit Medical Systems, Inc. · Sep 2003