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Balloon Catheter

FDA UDI

Class II (US FDA UDI)

by Microvention Inc.

Identity

Trade Name
Balloon Catheter FDA UDI
Generic Name
Intravascular occluding balloon catheter, image-guided FDA UDI
Device Name
Scepter C FDA UDI
Model / Reference
BC0410C-ID-2 FDA UDI
Description
Scepter C FDA UDI

Identifiers

Catalog Number
BC0410C FDA UDI
Primary DI / UDI-DI
00842429106884 FDA UDI
FDA Product Code
MJN FDA UDI
DQY FDA UDI
GMDN Term
Intravascular occluding balloon catheter, image-guided FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
870.1250 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: Intravascular occluding balloon catheter, image-guided

Balloon Catheter by Microvention Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microvention Inc.

Sources (1)

  • FDA UDI 89f361b2-f3b7-4168-b8c5-d92595e65a45 36 fields · synced Jun 8, 2026