Medical Device Manufacturer · US , Ithaca , NY

Transonic Systems, Inc.

16 submissions · 16 cleared · Since 1988
16
Total
16
Cleared
0
Denied

Transonic Systems, Inc. — FDA 510(k) Submissions

Transonic Systems, Inc. has submitted 16 FDA 510(k) premarket notifications since 1988, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Flowmeter, Blood, Cardiovascular, Computer, Diagnostic, Pre-programmed, Single-function, System, Hemodialysis, Access Recirculation Monitoring, Accessories, Blood Circuit, Hemodialysis, Catheter, Flow Directed . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
TRANSONIC TISSUE PERFUSION MONITOR
K140740 · DPW Flowmeter, Blood,... · Cardiovascular
Jul 2015 485d
TRANSONIC ELSA SYSTEM
K134051 · DXG Computer, Diagnostic,... · Cardiovascular
Jan 2015 394d
TRANSONIC HCM 103 SYSTEM
K134035 · DXG Computer, Diagnostic,... · Cardiovascular
Sep 2014 260d
TRANSONIC HCM 102 SYSTEM
K140017 · DXG Computer, Diagnostic,... · Cardiovascular
Sep 2014 257d
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
K113821 · DXG Computer, Diagnostic,... · Cardiovascular
Sep 2012 255d
AUREFLO MONITORING SYSTEM
K112657 · DPW Flowmeter, Blood,... · Cardiovascular
Dec 2011 99d
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
K080116 · DXG Computer, Diagnostic,... · Cardiovascular
Sep 2008 236d
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
K033424 · DPW Flowmeter, Blood,... · Cardiovascular
Dec 2003 49d
TRANSONIC SYRINGE WARMER, MODEL SYR-1000
K022963 · MQS System, Hemodialysis,... · Gastroenterology & Urology
Dec 2002 89d
TRANSONIC FLOW-QC SET MODEL ADT1010
K021571 · MQS System, Hemodialysis,... · Gastroenterology & Urology
Aug 2002 90d
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101
K010253 · DYG Catheter, Flow Directed · Cardiovascular
Mar 2002 417d
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
K002816 · KOC Accessories, Blood... · Gastroenterology & Urology
Nov 2000 72d
TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO
K980906 · MQS System, Hemodialysis,... · Gastroenterology & Urology
Oct 1998 210d
HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
K960817 · MQS System, Hemodialysis,... · Gastroenterology & Urology
Feb 1997 349d
ADVANCE LASER FLOWMETER, ALF 21
K903633 · DPW Flowmeter, Blood,... · Cardiovascular
Oct 1990 60d
TRANSONIC FLOWMETER
K872048 · DPW Flowmeter, Blood,... · Cardiovascular
Jun 1988 390d
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