# K033424: Angioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde Catheter, Models HVT100, ADT1001, ADT1002

- Pathway: 510(k) (Special)
- Applicant: Transonic Systems, Inc.
- Decided: Dec 11, 2003 after 49 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010253 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010253: Angio Flow Thermodilution Catheter, Model AF-Cath-01; Angioflow Meter, Models HQ100 and HQ101, Transonic Systems, Inc. (2002) Summary page 1.

## Indications for use
The Transonic AngioFlow meter and catheter are indicated for use during angioplasty procedures to verify the flow before, during, and after treatment. The system is intended for the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal changes induced by a bolus injection of normal saline and thermal-dilution principles to calculate blood flow.

Source page: https://510kreport.com/device/K033424
Methodology: https://510kreport.com/methodology