510(k) K870394
- Device
- Hydrophobic #6194418/hydraphilic #6104418 Filters
- Applicant
- CLINICAL CONNECTIONS, INC.
- 510(k) number
- K870394
- Product code
- FIB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-03-03
- Date received
- 1987-01-30
- Regulation
- 876.5820
- Classification name
- Protector, Transducer, Dialysis
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEITH ANTAL
- Address
- P.O. Box 238 9287 Smucker Rd. Orrville OH US 44667 44667
FDA Registration Numbers#
- 3000247873
- 3003464075
- 8041145
- 3032143970
- 3013217742
- 9612003
- 1424263
- 3002807314
- 3004111573
- 8020892
- 9616074
- 8030665
- 1932668
- 1649518
- 3015335038
- 9680579
- 3013671177
- 1225714
- 1526534
- 1650907
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FIB#
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|---|---|---|---|
| K240164 | NovaLine SP-C35 Transducer Protector (956007) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2024-06-28 |
| K072988 | NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 | Nipro Medical Corporation | 2008-02-21 |
| K001971 | HEMODIALYSIS TUBING SETS | Ofi Biomedica S.P.A. | 2001-05-24 |
| K010264 | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET | Nipro Medical Corp. | 2001-04-27 |
| K001465 | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET | Nipro Medical Corp. | 2000-12-05 |
| K003445 | FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 | Fresenius Medical Care North America | 2000-12-01 |
| K000702 | BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR | Fresenius Medical Care North America | 2000-06-07 |
| K983076 | MEDISYSTEMS TRANSDUCER PROTECTOR | Medisystems Corp. | 1998-11-25 |
| K964337 | BETTER-BLADDER (BB) | Circulatory Technology, Inc. | 1997-05-23 |
| K970536 | MEDISYSTEMS TRANDUCER PROTECTOR | Medisystems Corp. | 1997-05-12 |
| K934069 | MILLEX, DUALEX (PLUS, ULTRA) | Millipore Corp. | 1994-04-21 |
| K925978 | MPC-80 TRANSDUCER | Molded Products, Inc. | 1994-01-14 |
| K915593 | TRANSDUCER PROTECTOR | United Pharmaceutical and Medical Supply Co. | 1992-07-01 |
| K912394 | TRANSDUCER PROTECTOR | Filtertek, Inc. | 1991-08-30 |
| K910821 | TRANSDUCER PROTECTOR | Gelman Sciences, Inc. | 1991-08-12 |