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Z-6™

FDA UDI

Class II (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name
Z-6™ FDA UDI
Generic Name
Cardiac septostomy catheter, balloon FDA UDI
Device Name
Z6135 Atrio Balloon Catheter 13.5mm FDA UDI
Model / Reference
611051 FDA UDI
Description
Z6135 Atrio Balloon Catheter 13.5mm FDA UDI

Identifiers

Catalog Number
611051 FDA UDI
Primary DI / UDI-DI
04046955718054 FDA UDI
510(k) Number
K211910 FDA UDI
FDA Product Code
DXF FDA UDI
GMDN Term
Cardiac septostomy catheter, balloon FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5175 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 septostomy catheter, balloon

Z-6™ by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac septostomy catheter, balloon.

Cleared under the same submission

K211910 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 9bf4ec84-0dab-406e-b034-0d0152856e36 38 fields · synced May 30, 2026