Cleared Special

K071330 - GALTSTICK INTRODUCER SYSTEM

K071330 is an FDA 510(k) clearance for GALTSTICK INTRODUCER SYSTEM, manufactured by Galt Medical Corp.. The device is a Class 2 Cardiovascular device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K071330

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 125d · This submission: 173d
Pathway characteristics
Modification to existing cleared device.

DRE Device Classification - Class 2, Special Controls

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 104
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K071330.
AVALON ELITE VASCULAR ACCESS KIT
K081940 · Avalon Laboratories, LLC · Nov 2008
HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
K082075 · Hansen Medical, Inc. · Aug 2008
PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
K073035 · Merit Medical Systems, Inc. · Nov 2007
ESTECH PERCUTANEOUS INSERTION DILATOR KIT
K070749 · Coombs Medical Device Consulting · Oct 2007
PRELUDE SHEATH INTRODUCER
K070159 · Merit Medical Systems, Inc. · Jun 2007
STARCLOSE HEX-HUB DILATOR
K062554 · Abbott Vascular, Inc. · Feb 2007
K071330 · GALTSTICK INTRODUCER SYSTEM
Download PDF FDA Summary Galt Medical Corp.