# K955175: Acs Anchor Exchange Device

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Cardiovascular Systems, Inc.
- Decided: Apr 5, 1996 after 144 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- 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) The Magnet Exchange Device: named in the summary without a submission number

## Indications for use
The ACS ANCHOR™ Exchange Device is used within a guiding catheter to facilitate the exchange of an interventional device while maintaining the position of a guide wire within the vasculature.

Source page: https://510kreport.com/device/K955175
Methodology: https://510kreport.com/methodology