# K924607: Arrow Fischell Kink Resist Percut Sheath Intro Set

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Apr 22, 1993 after 223 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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.
194 later devices descend from it; 8 cite it directly.
14 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K963320: TFX Medical Guidewire (1996), 103 descendants of its own
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218 (2001), 89 descendants of its own
- K013517: 10600 Deflectable Catheter System, Model 10600 (2002), 80 descendants of its own
- K012812: Carotid Guiding Sheath (2001), 69 descendants of its own
- K051601: Pinnacle Destination Peripheral Guiding Sheath (2005), 60 descendants of its own

## Recalls of this device
- Jan 12, 2016 · Class II · Z-1064-2016: Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to
- Feb 11, 2009 · Not classified · Z-1491-2009: 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.
- Oct 22, 2003 · Not classified · Z-0088-04: package lid identifies the contents incorrectly

Source page: https://510kreport.com/device/K924607
Methodology: https://510kreport.com/methodology