Cleared Traditional

SINC Support Catheter (K233350) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233350 · Reflow Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
132d
Days
Class 2
Risk

K233350 is an FDA 510(k) clearance for the SINC Support Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Reflow Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on February 8, 2024 after a review of 132 days - within the typical 510(k) review window.

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 Reflow Medical, Inc. devices

Submission Details

510(k) Number K233350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date February 08, 2024
Days to Decision 132 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
7d slower than avg
Panel avg: 125d · This submission: 132d
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 318
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K233350.
React 71 Catheter
K241177 · Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular · May 2024
APRO 55 Catheter
K234115 · Alembic, LLC · Mar 2024
SENDERO Microcatheter
K240384 · Okami Medical, Inc. · Mar 2024
WATCHMAN TruSteer Access System (M635TU90050)
K240018 · Boston Scientific Corporation · Feb 2024
Teleport XT Microcatheter
K231608 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Jan 2024
TriSalus TriGuideTM Guiding Catheter
K233858 · Trisalus Life Sciences · Dec 2023