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Z-Med Ii X™

FDA UDI

Class II (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name
Z-MED II X™ FDA UDI
Generic Name
Cardiac valvuloplasty catheter FDA UDI
Device Name
Z-MED II-X 25X3X14X9X100X.035 PDZ748 FDA UDI
Model / Reference
618748 FDA UDI
Description
Z-MED II-X 25X3X14X9X100X.035 PDZ748 FDA UDI

Identifiers

Catalog Number
618748 FDA UDI
Primary DI / UDI-DI
04046964316159 FDA UDI
510(k) Number
K022722 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Cardiac valvuloplasty catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

No

FDA UDI

Category: Cardiac valvuloplasty catheter

The Z-MED II X is a versatile cardiac valvuloplasty catheter designed for percutaneous dilatation of commissural fusion in stenotic mitral valves, annular, cuspal, and calcific nodular fractures, leaflet tearing in pulmonic valve stenosis, and percutaneous balloon pericardiotomy. This single-use device features a sterile flexible tube with an inflatable balloon for improved cusp mobility in adult calcific aortic stenosis.

Similar devices

Also classified as Cardiac valvuloplasty catheter.

Cleared under the same submission

K022722 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B Braun Interventional Systems, Inc

Sources (1)

  • FDA UDI 794d347c-0eb6-435b-ae6f-d1781fb4b373 37 fields · synced Jul 17, 2026