Cleared Special

K122394 - RUBICON 18 SUPPORT CATHETER

K122394 is an FDA 510(k) clearance for RUBICON 18 SUPPORT CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 23-day FDA review.

K122394 · 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
23d
Days
Class 2
Risk

K122394 is an FDA 510(k) clearance for the RUBICON 18 SUPPORT CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on August 30, 2012 after a review of 23 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 - K122394

510(k) Number K122394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2012
Decision Date August 30, 2012
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
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 - DQY Catheter, Percutaneous

All 878
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K122394.
PENUMBRA DDC CATHETERS
K122772 · Penumbra, Inc. · Nov 2012
ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
K121219 · Medtronic, Inc. · Sep 2012
TYSHAK NUCLEUS
K121859 · NuMED, Inc. · Aug 2012
AMPLATZER TORQVUE FX
K121611 · Aga Medical Corporation · Aug 2012
ARMADA 14XXT PTA CATHETER
K121352 · Abbott Vascular · Aug 2012
CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
K120781 · Fuji Systems Corp. · Aug 2012
K122394 · RUBICON 18 SUPPORT CATHETER
Download PDF FDA Summary Boston Scientific Corp