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Eclipse 2l

FDA UDI

Class II (US FDA UDI)

by Balt Usa Llc

Identity

Trade Name
ECLIPSE 2L FDA UDI
Generic Name
Intravascular occluding balloon catheter, image-guided FDA UDI
Device Name
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. FDA UDI
Model / Reference
ECL2L6x12 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
00818053022968 FDA UDI
510(k) Number
K183045 FDA UDI
FDA Product Code
DQY FDA UDI
MJN FDA UDI
GMDN Term
Intravascular occluding balloon catheter, image-guided FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
870.4450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 160 Centimeter FDA UDI
Catheter Inner Diameter — 0.016 Inch FDA UDI

Category: Intravascular occluding balloon catheter, image-guided

Eclipse 2l by Balt Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular occluding balloon catheter, image-guided.

Cleared under the same submission

K183045 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Balt Usa Llc

Sources (1)

  • FDA UDI d5a1deac-1294-4895-b7a7-d469cd1ee3ff 38 fields · synced May 30, 2026