# K880231: Modified Pruitt Irrigation & Occlusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ideas For Medicine, Inc.
- Decided: May 25, 1988 after 133 days
- Product code: DQT (Occluder, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.1370
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Apr 11, 2025 · Class II · Z-1752-2025: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

Source page: https://510kreport.com/device/K880231
Methodology: https://510kreport.com/methodology