# K781846: Adapter, Catheter Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Dec 12, 1978 after 41 days
- Product code: KGZ (Accessories, Catheter)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: 3 (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
- Jun 7, 2010 · Not classified · Z-2274-2010: Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affe
- Dec 15, 2009 · Not classified · Z-1538-2010: Some central venous catheter sets had the incorrect lid stock.
- Feb 11, 2009 · Not classified · Z-1493-2009: Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

Source page: https://510kreport.com/device/K781846
Methodology: https://510kreport.com/methodology