FDA.reportPublic FDA data

Prestige Coil System

Primary DI
00818053027475
Brand
Prestige Coil System
Company
BALT USA LLC
Model
PRES4510CPKPL
Device description
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
Published
2021-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200030000Optima Coil SystemBalt USA, LLC2020-02-01HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818053027475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818053027475008180530274758180530274750818053027475

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at a controlled room temperature in a dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-949-788-1443customerservice@balt-usa.com

Regulatory Flags#

DUNS number
945543689
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840303712053Prestige Coil SystemPRESPACK30N/A2026-07-14
00840303712077Prestige Coil SystemPRESPACK65N/A2026-07-14
00840303712091Prestige Coil SystemPRESPACK55N/A2026-07-14
00840303712107Prestige Coil SystemPRESPACK55N/A2026-07-14
00840303714521Optima Coil System (OptiOne Coil System)OPTIONE4SN/A2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)OPTIONE4MN/A2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)OPTIONE4LN/A2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)OPTIONE45SN/A2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)OPTIONE45MN/A2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)OPTIONE45LN/A2026-07-06
00840303714583Optima Coil System (OptiOne Coil System)OPTIONE5SN/A2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)OPTIONE5MN/A2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)OPTIONE5LN/A2026-07-06
00840303714613Optima Coil System (OptiOne Coil System)OPTIONE5XLN/A2026-07-06
00840303714620Optima Coil System (OptiOne Coil System)OPTIONE55SN/A2026-07-06
00840303714637Optima Coil System (OptiOne Coil System)OPTIONE55MN/A2026-07-06
00840303714644Optima Coil System (OptiOne Coil System)OPTIONE55LN/A2026-07-06
00840303714651Optima Coil System (OptiOne Coil System)OPTIONE55XLN/A2026-07-06
00840303714668Optima Coil System (OptiOne Coil System)OPTIONE6SN/A2026-07-06
00840303714675Optima Coil System (OptiOne Coil System)OPTIONE6MN/A2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840303712053Prestige Coil SystemBALT USA LLCKRD2026-07-14
00840303712077Prestige Coil SystemBALT USA LLCKRD2026-07-14
00840303712091Prestige Coil SystemBALT USA LLCKRD2026-07-14
00840303712107Prestige Coil SystemBALT USA LLCKRD2026-07-14
06958698053355Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053362Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053379Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053386Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053393Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053409Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053416Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053423Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053430Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053447Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053454Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053461Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053478Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053485Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053492Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053508Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
07613327635096InZone ISTStryker CorporationKRD2026-07-08
00840303714521Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714583Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06