# K945461: Piton (TM) Y-Pack and Piton (TM) Tri-Pack)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronics Interventional Vascular
- Decided: Feb 3, 1995 after 88 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 1 cites it directly.
0 of 31 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
- K031211: Attain Prevail Steerable Catheter Set, Model 6228CTH (2003), 29 descendants of its own
- K042194: Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery (2004), 17 descendants of its own
- K053431: Attain Select II 6248DEL Delivery Catheter System (2006), 14 descendants of its own
- K080428: Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters for Left Heart Delivery (2008), 13 descendants of its own
- K090659: Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart Delivery (2009), 12 descendants of its own

Source page: https://510kreport.com/device/K945461
Methodology: https://510kreport.com/methodology