# K882803: ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Cardiovascular Systems, Inc.
- Decided: Sep 16, 1988 after 71 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
77 later devices descend from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012241: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 (2002), 76 descendants of its own
- K052240: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 (2005), 75 descendants of its own
- K063222: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 (2006), 73 descendants of its own
- K072558: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 (2007), 67 descendants of its own
- K083287: Avivo Mobile Patient Management System (2009), 57 descendants of its own

Source page: https://510kreport.com/device/K882803
Methodology: https://510kreport.com/methodology