# K981788: Scimed 6 French Wiseguide Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: Aug 18, 1998 after 90 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974684 (1998). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974684: Scimed 7 French Wiseguide Guide Catheter, Scimed Life Systems, Inc. (1998) Summary page 2.
- (no number) 6 French Cyber Guide Catheters: named in the summary without a submission number
- (no number) Cordis® Corporation 6 French Vista Brite Tip™ Guide Catheters: named in the summary without a submission number

## Most influential descendants
- K092372: Heartrail Iii Guiding Catheter (2009), 2 descendants of its own
- K132556: Sheathless Eaucath Coronary Guide Catheter (2013), 0 descendants of its own
- K113335: Heartrail Iii Guiding Catheter (2012), 0 descendants of its own

## 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 6 French Wiseguide guide catheter is intended for use in general intravascular and coronary applications. It provides a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K981788
Methodology: https://510kreport.com/methodology