# K220699: Prestige Coil System

- Pathway: 510(k) (Special)
- Applicant: Bait USA, LLC
- Decided: Apr 8, 2022 after 29 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K951256 (1995). 66 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200030: Optima Coil System, Balt USA, LLC (2020) Summary page 4.

## Most influential descendants
- K251383: Prestige Coil System (Prestige Packing Line Extension) (2025), 0 descendants of its own

## Recalls of this device
- May 8, 2025 · Class II · Z-1989-2025: Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
- Jan 3, 2024 · Class II · Z-1042-2024: Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue rema

## Indications for use
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K220699
Methodology: https://510kreport.com/methodology