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Tyshak®

FDA UDI

Class II (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name
TYSHAK® FDA UDI
Generic Name
Cardiac valvuloplasty catheter FDA UDI
Device Name
PDC030 6MM X 2CM BALLOON CATH TYSHAK SP FDA UDI
Model / Reference
610509 FDA UDI
Description
PDC030 6MM X 2CM BALLOON CATH TYSHAK SP FDA UDI

Identifiers

Catalog Number
610509 FDA UDI
Primary DI / UDI-DI
04046964329708 FDA UDI
510(k) Number
K931009 FDA UDI
K991977 FDA UDI
FDA Product Code
LIT 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

Tyshak® by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac valvuloplasty catheter.

Cleared under the same submission

K931009 also covers:

K991977 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 20323c3e-9fdd-4a93-9e3e-d06c2e516720 37 fields · synced Jun 1, 2026