Cleared Traditional

K133633 - CHOCOLATE PTCA BOLLOON CATHETER

K133633 is an FDA 510(k) clearance for CHOCOLATE PTCA BOLLOON CATHETER, manufactured by Trireme Medical, Inc.. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K133633 · Trireme Medical, Inc. · Cardiovascular device
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Jun 2014
Decision
188d
Days
Class 2
Risk

K133633 is an FDA 510(k) clearance for the CHOCOLATE PTCA BOLLOON CATHETER. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Trireme Medical, Inc. (Pleasanton, US). The FDA issued a Cleared decision on June 2, 2014 after a review of 188 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - 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 Trireme Medical, Inc. devices

FDA 510(k) Submission Details - K133633

510(k) Number K133633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2013
Decision Date June 02, 2014
Days to Decision 188 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 125d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOX Device Classification - Class 2, Special Controls

Product Code LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.
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 - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 52
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K133633.
NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
K141090 · Medtronic, Inc. · Aug 2014
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
K141236 · Boston Scientific Corporation · Aug 2014
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
K134031 · Boston Scientific Corporation · Jul 2014
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
K130391 · Boston Scientific Corp · Jul 2013
MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
K123279 · Abbott Vascular · Jan 2013
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
K121196 · Boston Scientific Corp · Aug 2012