Ascendra Balloon Aortic Valvuloplasty Catheter

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER FDA UDI
Generic Name: Cardiac valvuloplasty catheter FDA UDI
Model / Reference: 9100BAVC FDA UDI

Identifiers

Catalog Number: 9100BAVCA FDA UDI
Primary DI / UDI-DI: 00690103191783 FDA UDI
510(k) Number: K142199 FDA UDI
FDA Product Code: OZT FDA UDI
GMDN Term: Cardiac valvuloplasty catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1255 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiac valvuloplasty catheter

Ascendra Balloon Aortic Valvuloplasty Catheter by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Edwards Lifesciences LLC

Sources (1)

FDA UDI 6af20a12-17d4-47c1-b711-b5e174650164 36 fields · synced Jun 8, 2026