FDA.reportPublic FDA data

Prestige Coil System

Primary DI
00818053027390
Brand
Prestige Coil System
Company
BALT USA LLC
Model
PRES3535CXPPL
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
00818053027390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818053027390008180530273908180530273900818053027390

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
00810068568998Next Generation 088 CatheterNG088110N/A2026-10-01
00840303713104Next Generation 088 CatheterNG088115N/A2026-10-01
00840303713128Carrier XL Delivery CatheterCR8088142N/A2025-10-24
00840303713135Carrier XL Delivery CatheterCR8088162N/A2025-10-24
00840303713470Carrier XL Delivery CatheterCR8088152N/A2025-10-24
00840303713593Stellar Guide CatheterSTLR071125N/A2025-08-19
00840303713609Stellar Guide CatheterSTLR081105N/A2025-08-19
00840303713616Stellar Guide CatheterSTLR081115N/A2025-08-19
00840303713531Stellar Guide CatheterSTLR071105N/A2025-06-09
00840303713548Stellar Guide CatheterSTLR071110N/A2025-06-09
00840303713555Stellar Guide CatheterSTLR071115N/A2025-06-09
00840303713562Stellar Guide CatheterSTLR074105N/A2025-06-09
00840303713579Stellar Guide CatheterSTLR074110N/A2025-06-09
00840303713586Stellar Guide CatheterSTLR074115N/A2025-06-09
00840303713487Carrier™ Delivery CatheterCR7071162N/A2025-04-02
00840303713494Carrier™ Delivery CatheterCR7074162N/A2025-04-02
00840303713500Carrier™ Delivery CatheterCR8081162N/A2025-04-02
00840303711780MEGA Ballast Distal Access PlatformMEGABT09180N/A2025-02-19
00840303711797MEGA Ballast Distal Access PlatformMEGABT09190N/A2025-02-19
00840303711803MEGA Ballast Distal Access PlatformMEGABT091100N/A2025-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150044177Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00199150044184Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00199150044191Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00199150044207Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00810169723586swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723593swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723609swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723616swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723623swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723630swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723647swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723654swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723661swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723678swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723685swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723692swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723708swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169724217Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724224Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724231Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724248Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724255Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724262Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724279Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724286Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
10886704076957DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076971DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076988DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077022DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077039DELTAFILLCerenovus, Inc.KRD2016-11-16