Better-Bladder (Bb)
by Circulatory Technology, Inc. 2 variants
510(k) K964337
Better-Bladder (Bb) is a medical device (FDA Class II; FDA product code FIB, Protector, Transducer, Dialysis) made by Circulatory Technology, Inc., cleared under FDA 510(k) K964337 on 23 May 1997, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964337 | Date23 May 1997 | StatusActive |
Official records
- FDA 510(k) database K964337
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FIB
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
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- HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS by Clinical Connections, Inc.
- MPC-80 TRANSDUCER by MOLDED PRODUCTS INC.