FDA.report

510(k) K223386

Device
Optima Coil System
Applicant
Balt USA, LLC
510(k) number
K223386
Product code
HCG
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-06
Date received
2022-11-07
Regulation
882.5950
Classification name
Device, Neurovascular Embolization
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Kavita Chandrashekar
Address
29 Parker Irvine CA US 92618 92618

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00810068568837Optima Coil SystemBALT USA LLC2024-10-07
00810068568691Optima Coil SystemBALT USA LLC2024-10-07
00810068568714Optima Coil SystemBALT USA LLC2024-10-07
00810068568721Optima Coil SystemBALT USA LLC2024-10-07
00810068568738Optima Coil SystemBALT USA LLC2024-10-07
00810068568745Optima Coil SystemBALT USA LLC2024-10-07
00810068568752Optima Coil SystemBALT USA LLC2024-10-07
00810068568769Optima Coil SystemBALT USA LLC2024-10-07
00810068568776Optima Coil SystemBALT USA LLC2024-10-07
00810068568783Optima Coil SystemBALT USA LLC2024-10-07
00810068568790Optima Coil SystemBALT USA LLC2024-10-07
00810068568806Optima Coil SystemBALT USA LLC2024-10-07
00810068568813Optima Coil SystemBALT USA LLC2024-10-07
00810068568820Optima Coil SystemBALT USA LLC2024-10-07
00810068568974Optima Coil SystemBALT USA LLC2024-10-07
00810068568844Optima Coil SystemBALT USA LLC2024-10-07
00810068568851Optima Coil SystemBALT USA LLC2024-10-07
00810068568868Optima Coil SystemBALT USA LLC2024-10-07
00810068568875Optima Coil SystemBALT USA LLC2024-10-07
00810068568882Optima Coil SystemBALT USA LLC2024-10-07
00810068568899Optima Coil SystemBALT USA LLC2024-10-07
00810068568905Optima Coil SystemBALT USA LLC2024-10-07
00810068568912Optima Coil SystemBALT USA LLC2024-10-07
00810068568929Optima Coil SystemBALT USA LLC2024-10-07
00810068568936Optima Coil SystemBALT USA LLC2024-10-07
00810068568943Optima Coil SystemBALT USA LLC2024-10-07
00810068568950Optima Coil SystemBALT USA LLC2024-10-07
00810068568967Optima Coil SystemBALT USA LLC2024-10-07

Other 510(k) Records For Product Code HCG

510(k)DeviceApplicantDecision date
K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2026-05-20
K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC2026-01-27
K252694Target Detachable CoilStryker Neurovascular2025-12-11
K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular2025-10-17
K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC2025-09-26
K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2024-09-30
K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC2024-09-27
K242243Target Detachable CoilsStryker Neurovscular2024-08-29
K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2024-01-10
K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular2023-11-07
K230284Penumbra LP Coil SystemPenumbra, Inc.2023-10-25
K222533Target Tetra Detachable CoilsStryker Neurovascular2022-12-14
K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil SystemsMedos International SARL2022-07-14
K212455InZone Detachment SystemStryker Neurovascular2021-11-16
K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2021-09-01