Identity
- Trade Name
- TYSHAK Mini® FDA UDI
- Generic Name
- Cardiac valvuloplasty catheter FDA UDI
- Device Name
- SO095 TYSHAK MINI 4MM, 1 CM, 3 FR FDA UDI
- Model / Reference
- 611994 FDA UDI
- Description
- SO095 TYSHAK MINI 4MM, 1 CM, 3 FR FDA UDI
Identifiers
- Catalog Number
- 611994 FDA UDI
- Primary DI / UDI-DI
- 04046964339813 FDA UDI
- 510(k) Number
- K003276 FDA UDI
- FDA Product Code
- LIT FDA UDIDQY 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 Mini® 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.
- VIDA® — Bard Peripheral Vascular · Class II
- VIDA® — Bard Peripheral Vascular · Class II
- Inoue Balloon Catheter — Toray Industries, Inc. · Class III
- ValvuloPro® — Dongguan TT Medical, Inc. · Class II
- VIDA — Bard Peripheral Vascular · Class II
- EDWARDS INTUITY ELITE DELIVERY SYSTEM — Edwards Lifesciences LLC · Class III
- ValvuloPro® — Dongguan TT Medical, Inc. · Class II
- TRUE DILATATION — Bard Peripheral Vascular · Class II
Cleared under the same submission
K003276 also covers:
- TYSHAK Mini® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK Mini® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK Mini® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK Mini® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK Mini® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK Mini® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK Mini® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK Mini® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK Mini® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK Mini® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK Mini® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK Mini® — B BRAUN INTERVENTIONAL SYSTEMS, INC
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
- B Braun Interventional Systems, Inc
Sources (1)
- FDA UDI 1c47b0ab-1dce-4989-857d-b59d8d12752b 37 fields · synced May 29, 2026