Cleared Traditional

K010253 - ANGIO FLOW THERMODILUTION CATHETER

Also marketed or referenced as:
ANGIOFLOW METER, MODELS HQ100 AND HQ101

K010253 is the FDA 510(k) clearance for ANGIO FLOW THERMODILUTION CATHETER by Transonic Systems, Inc.. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 417-day FDA review.

K010253 · Transonic Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
417d
Days
Class 2
Risk

K010253 is an FDA 510(k) clearance for the ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on March 19, 2002 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Transonic Systems, Inc. devices

Submission Details

510(k) Number K010253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2001
Decision Date March 19, 2002
Days to Decision 417 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
292d slower than avg
Panel avg: 125d · This submission: 417d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 41
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K010253.
Swang-Ganz IQ pulmonary artery catheter
K222117 · Edwards Lifesiences, LLC · Dec 2022
Swan-Ganz Catheters
K193466 · Edwards Lifesciences, LLC · Feb 2020
Swan Ganz Catheters
K160084 · Edwards Lifesciences, LLC · May 2016
ATTAIN 6215 VENOGRAM BALLOON CATHETER
K012225 · Medtronic Vascular · Aug 2001
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
K001063 · Baxter Healthcare Corp · Jul 2000
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
K955816 · Baxter Healthcare Corp · May 1997