# K010128: Cook Vascular Peel-Away Hemostasis Valve

- Pathway: 510(k) (Traditional)
- Applicant: Cook Vascular, Inc.
- Decided: Apr 25, 2002 after 464 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
38 later devices descend from it; 2 cite it directly.
5 of 39 devices 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.

## Most influential descendants
- K032312: Attain 6226DEF Deflectable Catheter Delivery System (2003), 37 descendants of its own
- K033989: Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 (2004), 35 descendants of its own
- K072313: Amplatzer Torqvue Delivery System (2007), 30 descendants of its own
- K083214: Amplatzer Torqvue  45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100 (2009), 10 descendants of its own
- K080757: Amplatzer Torqvue Low Profile Delivery System (2008), 7 descendants of its own

Source page: https://510kreport.com/device/K010128
Methodology: https://510kreport.com/methodology