20mm X 4cm X 130cm Edwards Balloon Catheter

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: 20MM X 4CM X 130CM EDWARDS BALLOON CATHETER FDA UDI
Generic Name: Cardiac valvuloplasty catheter FDA UDI
Device Name: EDWARDS BALLOON CATHETER FDA UDI
Model / Reference: 9350BC20 FDA UDI
Description: EDWARDS BALLOON CATHETER FDA UDI

Identifiers

Catalog Number: 9350BC20A FDA UDI
Primary DI / UDI-DI: 00690103191813 FDA UDI
510(k) Number: K140241 FDA UDI
K153069 FDA UDI
FDA Product Code: OZT FDA UDI
OMZ FDA UDI
GMDN Term: Cardiac valvuloplasty catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1255 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

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

20mm X 4cm X 130cm Edwards Balloon Catheter by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K140241 also covers:

K153069 also covers:

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 056b20d2-1f54-42db-bd10-b332049f34b6 38 fields · synced Jun 8, 2026