Identity
- Trade Name
- POT EUDAMEDPOT PTCA Balloon Dilatation Catheter FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- POT PTCA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 833-3510 EUDAMEDrev01 FDA UDI
Identifiers
- Catalog Number
- 833-3510 FDA UDI
- Primary DI / UDI-DI
- 06958481467222 EUDAMED06958481438536 FDA UDI
- Basic UDI-DI
- B-06958481467222 EUDAMED
- 510(k) Number
- K230705 FDA UDI
- FDA Product Code
- LOX FDA UDI
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
- GMDN Term
- Coronary angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5100 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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: Coronary angioplasty balloon catheter, cutting/scoring
Pot by BrosMed Medical Co., Ltd. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06958481467222 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- BrosMed Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000007501
- Authorised Representative
- Brosmed Medical B.V. NL-AR-000002616
Sources (2)
- EUDAMED 4b73efd2-6e44-45a0-8b31-1e32dd29cf24 61 fields · synced May 31, 2026
- FDA UDI 64301fbc-d2f4-43f1-90fd-c5f323088c65 34 fields · synced May 30, 2026