Protector, Transducer, Dialysis
FDA product code FIB · Class II (moderate risk) · 21 CFR 876.5820 · Gastroenterology, Urology
35510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Filtertek, Inc. 5
- Nipro Medical Corporation 3
- Medisystems Corp. 3
- Fresenius Medical Care North America 2
- Mediflex Intl. 2
- Clinical Connections, Inc. 1
- Molded Products, Inc. 1
- United Pharmaceutical and Medical Supply Co. 1
- Bain Medical Equipment (Guangzhou) Co., Ltd. 1
- Gelman Sciences, Inc. 1
- Arbo Medical, Inc. 1
- Akcess Medical Products, Inc. 1
- Cordis Corp. 1
- Bipore, Inc. 1
- Omni Intl., Inc. 1
- Galvin Industries, Inc. 1
- Gambro, Inc. 1
- Cp Medical 1
- Membrana 1
- Renalab 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240164 | NovaLine SP-C35 Transducer Protector (956007)FIB · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 06/28/2024SE |
| K072988 | Nipro Transducer Protector Tp-Sure, Model TPSURE+1FIB · Traditional | Nipro Medical Corporation | 02/21/2008SE |
| K001971 | Hemodialysis Tubing SetsFIB · Traditional | Ofi Biomedica S.P.A. | 05/24/2001SE |
| K010264 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming SetFIB · Traditional | Nipro Medical Corp. | 04/27/2001SE |
| K001465 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming SetFIB · Traditional | Nipro Medical Corp. | 12/05/2000SE |
| K003445 | Fresenius Viral Blocking Transducer Protector for Hemodialysis, Model 04-9500-2FIB · Special | Fresenius Medical Care North America | 12/01/2000SE |
| K000702 | Borla Transducer Protector & Haemotronic Transducer ProtectorFIB · Traditional | Fresenius Medical Care North America | 06/07/2000SE |
| K983076 | Medisystems Transducer ProtectorFIB · Traditional | Medisystems Corp. | 11/25/1998SE |
| K964337 | Better-Bladder (BB)FIB · Traditional | Circulatory Technology, Inc. | 05/23/1997SE |
| K970536 | Medisystems Tranducer ProtectorFIB · Traditional | Medisystems Corp. | 05/12/1997SE |
| K934069 | Millex, Dualex (Plus, Ultra)FIB · Traditional | Millipore Corp. | 04/21/1994SE |
| K925978 | MPC-80 TransducerFIB · Traditional | Molded Products, Inc. | 01/14/1994SE |
| K915593 | Transducer ProtectorFIB · Traditional | United Pharmaceutical and Medical Supply Co. | 07/01/1992SE |
| K912394 | Transducer ProtectorFIB · Traditional | Filtertek, Inc. | 08/30/1991SE |
| K911658 | Dialysis Trandsducer ProtectorFIB · Traditional | Tico Medical Instruments, Inc. | 08/12/1991SE |
| K910821 | Transducer ProtectorFIB · Traditional | Gelman Sciences, Inc. | 08/12/1991SE |
| K904912 | Transducer ProtectorFIB · Traditional | Filtertek, Inc. | 01/04/1991SE |
| K902788 | Clem TMFIB · Traditional | Arbo Medical, Inc. | 09/12/1990SE |
| K901409 | Transducer ProtectorFIB · Traditional | Filtertek, Inc. | 07/27/1990SE |
| K901996 | Filtertek PN 60650 Dialysis Transducer ProtectorFIB · Traditional | Filtertek, Inc. | 06/01/1990SE |
| K900841 | Hemodialysis Transducer ProtectorFIB · Traditional | Mediflex Intl. | 05/15/1990SE |
| K895856 | Medisystems Transducer ProtectorFIB · Traditional | Medisystems Corp. | 11/24/1989SE |
| K895281 | Transducer ProtectorFIB · Traditional | Filtertek, Inc. | 11/08/1989SE |
| K891752 | DA-46 Fluid BarrierFIB · Traditional | Akcess Medical Products, Inc. | 04/07/1989SE |
| K870394 | Hydrophobic #6194418/HYDRAPHILIC #6104418 FiltersFIB · Traditional | Clinical Connections, Inc. | 03/03/1987SE |
| K863496 | Mediflex Transducer ProtectorFIB · Traditional | Mediflex Intl. | 09/23/1986SE |
| K862015 | O.2 Micron Infection Resistant Hydrophobic FilterFIB · Traditional | Bipore, Inc. | 07/22/1986SE |
| K851734 | Omnimed Superior Transducer ProtectorFIB · Traditional | Omni Intl., Inc. | 05/23/1985SE |
| K851428 | Tranducer ProtectorFIB · Traditional | Galvin Industries, Inc. | 05/21/1985SE |
| K851230 | Gambro Pressure Monitor GuardsFIB · Traditional | Gambro, Inc. | 04/09/1985SE |
| K821268 | Transducer FilterFIB · Traditional | Cp Medical | 06/23/1982SE |
| K812162 | Hemodialysis Transducer ProtectorFIB · Traditional | Membrana | 09/24/1981SE |
| K812107 | Renalab Transducer Protector, .22 MicronFIB · Traditional | Renalab | 08/20/1981SE |
| K811859 | BactashieldFIB · Traditional | Tri-Med, Inc. | 08/07/1981SE |
| K811892 | Cordis Dow Sera Flo TM Transducer ProtFIB · Traditional | Cordis Corp. | 07/31/1981SE |