# K191229: TrapIt

- Pathway: 510(k) (Traditional)
- Applicant: Imds Operations B.V.
- Decided: Jan 21, 2020 after 258 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
Longest line of descent: 3 generations back to P860019 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162253: Trapper Exchange Device, Creganna Medical Aslo Business AS Cregganna Tactx Medical (2017) Summary page 4.

## Indications for use
The TrapIT Trapping Balloon Catheter is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. TrapIT Trapping Balloon Catheter is not intended for use outside of the guide catheter.

Source page: https://510kreport.com/device/K191229
Methodology: https://510kreport.com/methodology