FIB — Protector, Transducer, Dialysis Class II
FDA product code FIB covers "Protector, Transducer, Dialysis", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FIB
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240164 | bain medical equipment (guangzhou) co | NovaLine SP-C35 Transducer Protector (956007) | June 28, 2024 |
| K072988 | nipro medical corporation | NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 | February 21, 2008 |
| K001971 | ofi biomedica | HEMODIALYSIS TUBING SETS | May 24, 2001 |
| K010264 | nipro medical | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S | April 27, 2001 |
| K001465 | nipro medical | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S | December 5, 2000 |
| K003445 | fresenius medical care north america | FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 | December 1, 2000 |
| K000702 | fresenius medical care north america | BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR | June 7, 2000 |
| K983076 | medisystems | MEDISYSTEMS TRANSDUCER PROTECTOR | November 25, 1998 |
| K964337 | circulatory technology | BETTER-BLADDER (BB) | May 23, 1997 |
| K970536 | medisystems | MEDISYSTEMS TRANDUCER PROTECTOR | May 12, 1997 |
| K934069 | millipore | MILLEX, DUALEX (PLUS, ULTRA) | April 21, 1994 |
| K925978 | molded products | MPC-80 TRANSDUCER | January 14, 1994 |
| K915593 | united pharmaceutical and medical supply | TRANSDUCER PROTECTOR | July 1, 1992 |
| K912394 | filtertek | TRANSDUCER PROTECTOR | August 30, 1991 |
| K910821 | gelman sciences | TRANSDUCER PROTECTOR | August 12, 1991 |
| K911658 | tico medical instruments | DIALYSIS TRANDSDUCER PROTECTOR | August 12, 1991 |
| K904912 | filtertek | TRANSDUCER PROTECTOR | January 4, 1991 |
| K902788 | arbo medical | CLEM TM | September 12, 1990 |
| K901409 | filtertek | TRANSDUCER PROTECTOR | July 27, 1990 |
| K901996 | filtertek | FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR | June 1, 1990 |