# K992622: Intramax Iti Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Intratherapeutics, Inc.
- Decided: Sep 29, 1999 after 55 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: 1 generation back to K981191 (1999). 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)
- K981191: Iti Intramax Guide Catheter 91, 78 and 65, Intratherapeutics, Inc. (1999) Summary page 1.

## Indications for use
The IntraMax™ guide catheter is intended for intravascular introduction of diagnostic, therapeutic and interventional™ devices into the extracranial vasculature.

Source page: https://510kreport.com/device/K992622
Methodology: https://510kreport.com/methodology