Cleared Traditional

K223633 - Rubicon Control Support Catheter (H7493...

K223633 is the FDA 510(k) clearance for Rubicon Control Support Catheter (H7493... by Boston Scientific Corporation. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K223633 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
246d
Days
Class 2
Risk

K223633 is an FDA 510(k) clearance for the Rubicon™ Control Support Catheter (H749394323506A1). Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on August 8, 2023 after a review of 246 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Boston Scientific Corporation devices

Submission Details

510(k) Number K223633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2022
Decision Date August 08, 2023
Days to Decision 246 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
121d slower than avg
Panel avg: 125d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K223633.
Amulet™ Steerable Delivery Sheath
K232690 · Abbott Medical · Sep 2023
Ventrax™ Delivery System (VTR851)
K231246 · Merit Medical Systems, Inc. · Aug 2023
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
K232190 · Medtronic Vascular · Aug 2023
R2P Navicross
K231044 · Terumo Medical Corporation · Jul 2023
Micro Rx
K223728 · Imds Operations B.V. · Jul 2023
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
K230156 · Medtronic Vascular · Jun 2023