# K052459: 6248VAL Adjustable Valve

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jan 11, 2006 after 126 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K770977 (1977). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218, Medtronic Vascular (2001) Summary page 1.
- K012130: Attain LDS 6216 Left-Heart Delivery System, Medtronic Vascular (2001) Summary page 1.
- K031688: Rapido Cut-a-Way Rotating Hemostasis Valve, Guidant Corporation (2003) Summary page 1.
- K895580: Y-Adapter W/Thouy Borst, Angeion Corp. (1990) Summary page 1.

## Recalls of this device
- Aug 27, 2008 · Not classified · Z-2471-2008: Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve pac

## Indications for use
The Medtronic model 6248VAL adjustable valve is intended to minimize blood loss during percutaneous catheter procedures used to place cardiac leads and implant accessories such as guide wires and subselecting catheters.

Source page: https://510kreport.com/device/K052459
Methodology: https://510kreport.com/methodology