# K200030: Optima Coil System

- Pathway: 510(k) (Special)
- Applicant: Balt USA, LLC
- Decided: Feb 1, 2020 after 25 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K951256 (1995). 65 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172390: Optima Coil System, Blockade Medical, LLC (D.B.A. Balt Usa) (2018) Summary page 4.

## Most influential descendants
- K223386: Optima Coil System (2022), 3 descendants of its own
- K242582: Optima Coil System (OptiBlock Line Extension) (2024), 2 descendants of its own
- K252700: Optima Coil System (Optima Packing Coil System) (2025), 1 descendant of its own
- K220699: Prestige Coil System (2022), 1 descendant of its own
- K254221: Optima Coil System (OptiOne Coil System) (2026), 0 descendants of its own

## Recalls of this device
- May 8, 2025 · Class II · Z-1988-2025: 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-1041-2024: 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
- Sep 7, 2022 · Class II · Z-0103-2023: Product pouch label does not match up with carton label
- Jul 26, 2022 · Class II · Z-1680-2022: Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
- Jan 4, 2022 · Class II · Z-0660-2022: Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the po

## Indications for use
The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K200030
Methodology: https://510kreport.com/methodology