Identity
- Trade Name
- POLARx™ FDA UDI
- Generic Name
- Cardiac cryosurgical system catheter FDA UDI
- Device Name
- Cryoablation Balloon Catheter FDA UDI
- Model / Reference
- M004CRBS2150 FDA UDI
- Description
- Cryoablation Balloon Catheter FDA UDI
Identifiers
- Catalog Number
- M004CRBS2150 FDA UDI
- Primary DI / UDI-DI
- 08714729992677 FDA UDI
- PMA Number
- P220032 FDA UDI
- FDA Product Code
- OAE FDA UDI
- GMDN Term
- Cardiac cryosurgical system catheter FDA UDI
Classification
- Device Class
- Class III 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
Dimensions & Sizes
- Size
- Outer Diameter — 4 Millimeter FDA UDI
Category: Cardiac cryosurgical system catheter
POLARx™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P220032 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 6428a108-f9b2-4edc-a64f-afae9832862e 36 fields · synced May 30, 2026