# K970823: Scimed 8 French Wiseguide Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: Jun 3, 1997 after 89 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (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. The FDA summary names its predicate without a number.
- (no number) SCIMED® 8 French Cyber™ Guide Catheters: named in the summary without a submission number
- (no number) Cordis® Corporation 8 French Vista Brite Tip™ Guide Catheters: named in the summary without a submission number

## Recalls of this device
- Aug 5, 2009 · Not classified · Z-2013-2009: Boston Scientific is initiating a recall removal of numerous batches/lots of Wiseguide Guide Catheter, Impulse Angiographic (Diagnostic) Catheter, Expo Angiographic (Diagnostic) Catheter. Boston Scien
- Mar 11, 2009 · Not classified · Z-1470-2009: Boston Scientific has initiated a recall of the Wiseguide Guide Catheter. They have received reports of difficulties in connecting the product hubs with the Y-Adaptors and toughy borst connectors. If 

## Indications for use
SCIMED guide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature

Source page: https://510kreport.com/device/K970823
Methodology: https://510kreport.com/methodology