# K934541: Scimed 6 French Angiographic Catheter Modification

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: May 12, 1994 after 238 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K120495: Impulse and Expo Angiographic Catheter (2012), 1 descendant of its own
- K152605: Impulse Angiographic Catheter, Expo Angiographic Catheter (2015), 0 descendants of its own

## Recalls of this device
- Aug 5, 2009 · Not classified · Z-2015-2009: 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

Source page: https://510kreport.com/device/K934541
Methodology: https://510kreport.com/methodology