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HYBRID Guidewire

FDA UDI

Class II (US FDA UDI)

by Balt Usa Llc

Identity

Trade Name
HYBRID Guidewire FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnositc or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy. FDA UDI
Model / Reference
HYBRID007J FDA UDI
Description
HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnositc or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy. FDA UDI

Identifiers

Primary DI / UDI-DI
00818053022746 FDA UDI
510(k) Number
K182337 FDA UDI
FDA Product Code
MOF FDA UDI
DQX FDA UDI
GMDN Term
Cardiac/peripheral vascular guidewire, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 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

Category: Cardiac/peripheral vascular guidewire, single-use

HYBRID Guidewire by Balt Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac/peripheral vascular guidewire, single-use.

Cleared under the same submission

K182337 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 7be46bdf-688b-46f1-b3da-c34ce09a2d16 37 fields · synced Jun 8, 2026