Cleared Traditional

K133852 - APOLLO BALLOON DILATATION CATHETER

K133852 is an FDA 510(k) clearance for APOLLO BALLOON DILATATION CATHETER, manufactured by Brosmed Medical. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K133852 · Brosmed Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
274d
Days
Class 2
Risk

K133852 is an FDA 510(k) clearance for the APOLLO BALLOON DILATATION CATHETER. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Brosmed Medical (Dongguan, Guangdong, CN). The FDA issued a Cleared decision on September 19, 2014 after a review of 274 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.

FDA 510(k) Submission Details - K133852

510(k) Number K133852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2013
Decision Date September 19, 2014
Days to Decision 274 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
149d slower than avg
Panel avg: 125d · This submission: 274d
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 86
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K133852.
Chocolate PTCA Balloon Catheter
K150292 · Trireme Medical, LLC · Apr 2015
Euphora Rapid Exchange Balloon Dilatation Catheter
K143480 · Medtronic, Inc. · Apr 2015
FOXTROT NC PTCA Balloon Catheter
K143160 · Shanghai MicroPort Medical (Group) Co., Ltd. · Mar 2015
ARTIMES BALLOON DILATATION CATHETER
K141025 · Brosmed Medical · Sep 2014
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
K133852 · APOLLO BALLOON DILATATION CATHETER
Download PDF FDA Summary Brosmed Medical