FDA.reportPublic FDA data

ECLIPSE 2L

Primary DI
00818053022982
Brand
ECLIPSE 2L
Company
BALT USA LLC
Model
ECL2L6x15
Catalog number
N/A
Device description
ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. The guidewire lumen or the working lumen is DMSO compatible and can be used for infusion/delivery of diagnostic and therapeutic devices. The inflation lumen is used for the inflation and deflation of the balloon. The inflation and deflation of the balloon can be achieved independently of the presence of the guidewire. ECLIPSE 2L balloon catheter is equipped with a non-detachable low inflation pressure super compliant balloon welded to the distal end of the catheter.
Published
2019-07-15
Public version status
Update
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
MJNCatheter, Intravascular Occluding, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183045000Eclipse 2LBalt USA, LLC2019-04-30MJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818053022982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818053022982008180530229828180530229820818053022982

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Inner Diameter0.016Inch
Length160Centimeter

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
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00840303713135Carrier XL Delivery CatheterCR8088162N/A2025-10-24
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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
00840303711810MEGA Ballast Distal Access PlatformMEGABT091110N/A2025-02-19
00840303711827MEGA Ballast Distal Access PlatformMEGABT09980N/A2025-02-19

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