Cleared Traditional

K193420 - XO Cross Support Catheter

K193420 is the FDA 510(k) clearance for XO Cross Support Catheter by Transit Scientific. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K193420 · Transit Scientific · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
149d
Days
Class 2
Risk

K193420 is an FDA 510(k) clearance for the XO Cross Support Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Transit Scientific (Salt Lake City, US). The FDA issued a Cleared decision on May 6, 2020 after a review of 149 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 Transit Scientific devices

Submission Details

510(k) Number K193420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2019
Decision Date May 06, 2020
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
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 Consultant

University of Utah
Spencer Walker

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQY Catheter, Percutaneous

All 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K193420.
Benchmark BMX96 Access System
K201271 · Penumbra, Inc. · Jun 2020
Agilis HisPro Steerable Catheter With Electrodes
K200721 · Abbott (St. Jude Medical) · Jun 2020
Support Catheter
K200317 · Qxmedical, LLC · May 2020
Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter
K192558 · Mivi Neurovascular · Apr 2020
NovaCross CTO Microcatheter
K193322 · Nitiloop , Ltd. · Apr 2020
speX LP Support Catheter
K200094 · Reflow Medical · Mar 2020