# K981191: Iti Intramax Guide Catheter 91, 78 and 65

- Pathway: 510(k) (Traditional)
- Applicant: Intratherapeutics, Inc.
- Decided: Apr 7, 1999 after 370 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis Vista Brite Tip®: named in the summary without a submission number
- (no number) Mallinckrodt Trax Craven: named in the summary without a submission number
- (no number) SciMed Cyber guide catheters: named in the summary without a submission number

## Most influential descendants
- K992622: Intramax Iti Guide Catheter (1999), 0 descendants of its own

## Indications for use
The ITI IntraMAX™ Guide Catheter is intended for intravascular introduction of diagnostic, therapeutic and interventional devices into the extracranial vasculature.

Source page: https://510kreport.com/device/K981191
Methodology: https://510kreport.com/methodology