# K000956: Modification to Scimed 6F Impulse Angiographic Cathaters

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Apr 21, 2000 after 28 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K000956
Methodology: https://510kreport.com/methodology