# K832178: Amplatz Heparin Coated Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Aug 12, 1983 after 37 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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
- Aug 15, 2007 · Not classified · Z-0135-2008: The device is normally sold as sterile, however this lot was not sterilized and the device is not adequately labeled, as the label does not state whether the device is sterile or non-sterile and lacks

Source page: https://510kreport.com/device/K832178
Methodology: https://510kreport.com/methodology