# K810859: Single Use Seldinger/Cournand Perc. NDL

- Pathway: 510(k) (Traditional)
- Applicant: Procedure Products, Inc.
- Decided: Apr 11, 1981 after 12 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- 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
- Oct 27, 2015 · Class II · Z-0355-2016: The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle

Source page: https://510kreport.com/device/K810859
Methodology: https://510kreport.com/methodology