Identity
- Trade Name
- Pall LeukoGuard BC2 FDA UDI
- Generic Name
- Cardiopulmonary bypass system filter, blood/cardioplegia solution FDA UDI
- Device Name
- Pall LeukoGuard BC2 Blood Cardioplegia Filter FDA UDI
- Model / Reference
- BC2B FDA UDI
- Description
- Pall LeukoGuard BC2 Blood Cardioplegia Filter FDA UDI
Identifiers
- Catalog Number
- BC2B FDA UDI
- Primary DI / UDI-DI
- 05034480306104 FDA UDI
- 510(k) Number
- K902518 FDA UDI
- FDA Product Code
- DTM FDA UDI
- GMDN Term
- Cardiopulmonary bypass system filter, blood/cardioplegia solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Pore Size — 40 Micrometer FDA UDI
Category: Cardiopulmonary bypass system filter, blood/cardioplegia solution
The Pall LeukoGuard BC2 Blood Cardioplegia Filter is a sterile, porous device designed to be incorporated into blood/cardioplegia circuits during cardiopulmonary bypass to remove/reduce potentially harmful gaseous emboli, aggregated blood constituents, particulate matter (e.g., greater than 40 microns), and leukocytes. As a single-use implantable device, it is intended for use in cardiac surgery.
Cleared under the same submission
K902518 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Pall International SARL
Sources (1)
- FDA UDI b0f45dc1-16c9-4309-aff7-a1f08844e26a 37 fields · synced Jul 4, 2026