# K970401: Medi-Dyne Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Dyne, Inc.
- Decided: Aug 1, 1997 after 179 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.
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. The FDA summary names its predicate without a number.
- (no number) Cordis Corporation Coronary Guiding Catheter (Petite Brite Tip™ and Vista Brite Tip™ models): named in the summary without a submission number
- (no number) SCIMED Life Systems, Inc. Coronary Guiding Catheter (Triguide™ - Elite model): named in the summary without a submission number

## Indications for use
The Medi-Dyne, Inc. Coronary Guiding Catheter is designed to be used for the intravascular introduction of medical instruments into the coronary vascular system.

Source page: https://510kreport.com/device/K970401
Methodology: https://510kreport.com/methodology