# K992123: Scimed Impulse Angiographic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Aug 23, 1999 after 61 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.
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® Impulse Catheters: named in the summary without a submission number

## Recalls of this device
- 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

## 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/K992123
Methodology: https://510kreport.com/methodology