Cleared Special

K121667 - NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)

K121667 is an FDA 510(k) clearance for NC QUANTUM APEX PTCA DILATATION CATHETE..., manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Special 510(k) pathway after a 68-day FDA review.

K121667 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
68d
Days
Class 2
Risk

K121667 is an FDA 510(k) clearance for the NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL). Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on August 13, 2012 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - 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 - K121667

510(k) Number K121667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2012
Decision Date August 13, 2012
Days to Decision 68 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
57d faster than avg
Panel avg: 125d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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 K121667.
TAMARIN BLUE PTCA RX DILATATION CATHETER
K112735 · Natec Medical , Ltd. · Nov 2012
FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1
K122178 · Ostial Corporation · Oct 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
K121196 · Boston Scientific Corp · Aug 2012
FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM
K113775 · Ostial Corporation · Jun 2012
GLIDER PTCA BALLOON CATHETER
K121681 · Trireme Medical, Inc. · Jun 2012
TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
K121222 · Abbott Vascular · Jun 2012
K121667 · NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
Download PDF FDA Summary Boston Scientific Corp