Home / 510(k) Clearances / K033424

510(k) K033424

ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 by Transonic Systems, Inc. — Product Code DPW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 11, 2003
Date Received: October 23, 2003
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Flowmeter, Blood, Cardiovascular
Device Class: Class II
Regulation Number: 870.2100
Review Panel: CV
Submission Type

Other clearances by Transonic Systems, Inc.

K140740 — TRANSONIC TISSUE PERFUSION MONITOR (July 23, 2015)
K134051 — TRANSONIC ELSA SYSTEM (January 29, 2015)
K134035 — TRANSONIC HCM 103 SYSTEM (September 17, 2014)
K140017 — TRANSONIC HCM 102 SYSTEM (September 16, 2014)
K113821 — TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM (September 7, 2012)
K112657 — AUREFLO MONITORING SYSTEM (December 21, 2011)
K080116 — TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM (September 8, 2008)
K022963 — TRANSONIC SYRINGE WARMER, MODEL SYR-1000 (December 4, 2002)
K021571 — TRANSONIC FLOW-QC SET MODEL ADT1010 (August 12, 2002)
K010253 — ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ (March 19, 2002)

Other clearances for product code DPW

K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speake (November 20, 2025)
K251114 — FloPatch FP120 (June 20, 2025)
K243852 — Elfor-L (April 14, 2025)
K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
K223843 — FloPatch FP120 (May 3, 2023)
K222242 — FloPatch FP120 (December 9, 2022)
K213974 — GEM FLOW COUPLER Monitor (GEM1020M-2) (April 20, 2022)
K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)
K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (October 7, 2021)
K201114 — Bidop 7 (January 5, 2021)