# K963663: 11F Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific /International Technologies
- Decided: Jan 13, 1997 after 122 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 K822243 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911869: Ivt Guiding Catheter, Intensive Technology, Inc. (1991) Summary page 1.
- K822243: Guiding Catheter, Interventional Medical, Inc. (1982) Summary page 1.
- (no number) Devices for Vascular Intervention, Inc. (DVI), 11F Guiding Catheter: named in the summary without a submission number
- (no number) Cordis Webster, Inc., Multipurpose Guiding Catheter: named in the summary without a submission number

## Indications for use
The IVT 11F Guiding Catheter is a standard guiding catheter intended for use in the coronary vasculature as a conduit for other medical devices such as diagnostic and therapeutic catheters and guidewires. Thus, the IVT 11F Guiding Catheter acts to facilitate access for these other medical devices. This device is intended for single use only. IVT’s 11F Guiding Catheter is indicated for use during interventional diagnostic cardiovascular procedures in hospital settings which are appropriate for these types of procedures.

Source page: https://510kreport.com/device/K963663
Methodology: https://510kreport.com/methodology