# K780532: Percutaneous Sheath Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Apr 21, 1978 after 17 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 17 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
1 of 4 devices in its family (counting itself) has 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
- K202330: Impella XR Sheath Set (2020), 0 descendants of its own
- K112554: Transradial Artery Access Devices (2011), 0 descendants of its own
- K021723: Sheath Adapter, Model SA-09847 (2002), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2385-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Dec 20, 2019 · Class II · Z-1242-2020: Product lidstock contains the incorrect expiration date for the product
- May 23, 2018 · Class II · Z-2576-2018: Product contains dry natural rubber latex. Label states Latex Free.
- Apr 11, 2018 · Class II · Z-2031-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1977-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1976-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2011-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2032-2018: Product sterility may be compromised due to unsealed packaging.
- Dec 22, 2017 · Class II · Z-1329-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Nov 14, 2017 · Class II · Z-1158-2018: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during 
- Oct 26, 2017 · Class II · Z-1287-2018: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
- May 9, 2017 · Class II · Z-2329-2017: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- Aug 6, 2014 · Class II · Z-0066-2015: The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and 
- Apr 14, 2014 · Class II · Z-1713-2014: Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.
- Oct 9, 2013 · Class II · Z-0468-2014: There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.
- Mar 25, 2011 · Not classified · Z-2048-2011: Labeling discrepancy - the outer corrugate label as well as a card inside the package state the product contains dry natural rubber - this is not duplicated on the unit packaging.
- Dec 20, 2010 · Not classified · Z-0936-2011: Packaging may have been compromised, and sterility of product cannot be guaranteed.

Source page: https://510kreport.com/device/K780532
Methodology: https://510kreport.com/methodology