Cleared Special

K113769 - GPSCATH BALLON DILATATION CATHETER

K113769 is an FDA 510(k) clearance for GPSCATH BALLON DILATATION CATHETER, manufactured by Hotspur Technologies. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 29-day FDA review.

K113769 · Hotspur Technologies · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
29d
Days
Class 2
Risk

K113769 is an FDA 510(k) clearance for the GPSCATH BALLON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Hotspur Technologies (Mountain View, US). The FDA issued a Cleared decision on January 20, 2012 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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. Low regulatory complexity profile. 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 - K113769

510(k) Number K113769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2011
Decision Date January 20, 2012
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 381
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K113769.
FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
K120738 · Ostial Corporation · Mar 2012
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K120660 · Bard Peripheral Vascular, Inc. · Mar 2012
CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
K120677 · Trireme Medical, Inc. · Mar 2012
GLADIATOR PTA BALLOON DILATION CATHETER
K113681 · Boston Scientific · Jan 2012
ELM PTA BALLON DILATATION CATHETER
K113468 · Creagh Medical, Ltd. · Dec 2011
EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
K112513 · Natec Medical , Ltd. · Dec 2011