# K021723: Sheath Adapter, Model SA-09847

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Aug 8, 2002 after 76 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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: 1 generation back to K780532 (1978). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K780532: Percutaneous Sheath Introducer Kit, Arrow Intl., Inc. (1978) Summary page 1.
- K904608: Percutaneous Introducer Tray, Thomas Medical Products, Inc. (1990) Summary page 1.

## Recalls of this device
- Apr 11, 2018 · Class II · Z-2029-2018: Product sterility may be compromised due to unsealed packaging.

## Indications for use
The Arrow Sheath Adapter is utilized in conjunction with one-piece Percutaneous Sheath Introducer to permit venous access and catheter introduction into the central circulation.

Source page: https://510kreport.com/device/K021723
Methodology: https://510kreport.com/methodology