FDA Product Code
FDA Product Code FIB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 35 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240164 | NovaLine SP-C35 Transducer Protector (956007) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2024-06-28 | Traditional | PDF ↗ |
| K072988 | NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 | Nipro Medical Corporation | 2008-02-21 | Traditional | PDF ↗ |
| K001971 | HEMODIALYSIS TUBING SETS | Ofi Biomedica S.P.A. | 2001-05-24 | Traditional | PDF ↗ |
| K010264 | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET | Nipro Medical Corp. | 2001-04-27 | Traditional | PDF ↗ |
| K001465 | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET | Nipro Medical Corp. | 2000-12-05 | Traditional | PDF ↗ |
| K003445 | FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 | Fresenius Medical Care North America | 2000-12-01 | Special | PDF ↗ |
| K000702 | BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR | Fresenius Medical Care North America | 2000-06-07 | Traditional | PDF ↗ |
| K983076 | MEDISYSTEMS TRANSDUCER PROTECTOR | Medisystems Corp. | 1998-11-25 | Traditional | PDF ↗ |
| K964337 | BETTER-BLADDER (BB) | Circulatory Technology, Inc. | 1997-05-23 | Traditional | PDF ↗ |
| K970536 | MEDISYSTEMS TRANDUCER PROTECTOR | Medisystems Corp. | 1997-05-12 | Traditional | PDF ↗ |
| K934069 | MILLEX, DUALEX (PLUS, ULTRA) | Millipore Corp. | 1994-04-21 | Traditional | PDF ↗ |
| K925978 | MPC-80 TRANSDUCER | Molded Products, Inc. | 1994-01-14 | Traditional | PDF ↗ |
| K915593 | TRANSDUCER PROTECTOR | United Pharmaceutical and Medical Supply Co. | 1992-07-01 | Traditional | PDF ↗ |
| K912394 | TRANSDUCER PROTECTOR | Filtertek, Inc. | 1991-08-30 | Traditional | PDF ↗ |
| K910821 | TRANSDUCER PROTECTOR | Gelman Sciences, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K911658 | DIALYSIS TRANDSDUCER PROTECTOR | Tico Medical Instruments, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K904912 | TRANSDUCER PROTECTOR | Filtertek, Inc. | 1991-01-04 | Traditional | PDF ↗ |
| K902788 | CLEM TM | Arbo Medical, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K901409 | TRANSDUCER PROTECTOR | Filtertek, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K901996 | FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR | Filtertek, Inc. | 1990-06-01 | Traditional | PDF ↗ |
| K900841 | HEMODIALYSIS TRANSDUCER PROTECTOR | Mediflex Intl. | 1990-05-15 | Traditional | PDF ↗ |
| K895856 | MEDISYSTEMS TRANSDUCER PROTECTOR | Medisystems Corp. | 1989-11-24 | Traditional | PDF ↗ |
| K895281 | TRANSDUCER PROTECTOR | Filtertek, Inc. | 1989-11-08 | Traditional | PDF ↗ |
| K891752 | DA-46 FLUID BARRIER | Akcess Medical Products, Inc. | 1989-04-07 | Traditional | PDF ↗ |
| K870394 | HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS | Clinical Connections, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K863496 | MEDIFLEX TRANSDUCER PROTECTOR | Mediflex Intl. | 1986-09-23 | Traditional | PDF ↗ |
| K862015 | O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER | Bipore, Inc. | 1986-07-22 | Traditional | PDF ↗ |
| K851734 | OMNIMED SUPERIOR TRANSDUCER PROTECTOR | Omni Intl., Inc. | 1985-05-23 | Traditional | PDF ↗ |
| K851428 | TRANDUCER PROTECTOR | Galvin Industries, Inc. | 1985-05-21 | Traditional | PDF ↗ |
| K851230 | GAMBRO PRESSURE MONITOR GUARDS | Gambro, Inc. | 1985-04-09 | Traditional | PDF ↗ |
| K821268 | TRANSDUCER FILTER | Cp Medical | 1982-06-23 | Traditional | PDF ↗ |
| K812162 | HEMODIALYSIS TRANSDUCER PROTECTOR | Membrana | 1981-09-24 | Traditional | PDF ↗ |
| K812107 | RENALAB TRANSDUCER PROTECTOR, .22 MICRON | Renalab | 1981-08-20 | Traditional | PDF ↗ |
| K811859 | BACTASHIELD | Tri-Med, Inc. | 1981-08-07 | Traditional | PDF ↗ |
| K811892 | CORDIS DOW SERA FLO TM TRANSDUCER PROT | Cordis Corp. | 1981-07-31 | Traditional | PDF ↗ |
Product code FIB · Class II · Gastroenterology, Urology. Data: openFDA.