# K964859: Scimed 5 French Impulse Angiographic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: Feb 10, 1997 after 68 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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.
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. The FDA summary names its predicate without a number.
- (no number) SCIMED® 5 French EXPO™ Angiographic Catheter: named in the summary without a submission number
- (no number) Cordis® Corporation 5 F Infiniti™ Angiographic Catheter: named in the summary without a submission number

## 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-2014-2009: 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
- Nov 20, 2007 · Not classified · Z-0935-2008: Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device dur
- Jun 4, 2007 · Not classified · Z-1159-2007: Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.

## Indications for use
The SCIMED IMPULSE Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

Source page: https://510kreport.com/device/K964859
Methodology: https://510kreport.com/methodology