# K974684: Scimed 7 French Wiseguide Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: Feb 19, 1998 after 65 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 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)
- None. The FDA summary names its predicate without a number.
- (no number) SCIMED® 8 French Wiseguide™: named in the summary without a submission number
- (no number) 7 French Triguide®-Max Guide Catheters: named in the summary without a submission number
- (no number) Cordis® Corporation 7 French Vista Brite Tip™ Guide Catheters: named in the summary without a submission number

## Most influential descendants
- K981788: Scimed 6 French Wiseguide Guide Catheter (1998), 3 descendants of its own
- 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 
- May 22, 2006 · Not classified · Z-1102-06: Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid

## Indications for use
SCIMED 7 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/K974684
Methodology: https://510kreport.com/methodology