FDA.reportPublic FDA data

MEGA Ballast Distal Access Platform

Primary DI
00840303711797
Brand
MEGA Ballast Distal Access Platform
Company
BALT USA LLC
Model
MEGABT09190
Catalog number
N/A
Device description
MEGA Ballast Distal Access Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Published
2025-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242376000Next Generation Access PlatformBalt USA, LLC2024-12-30QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840303711797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840303711797008403037117978403037117970840303711797

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter0.108Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature and away from light

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
Manufacturing date on label
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

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Primary DI, Brand, Company table
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10841156108915TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-30
10801902196719ARROWTELEFLEX INCORPORATEDDQY2026-07-29
10841156108892TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-29
00884450419922SureCrossMerit Medical Systems, Inc.DQY2026-07-24
10841156108908TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-23
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