Borla Transducer Protector & Haemotronic Transducer Protector
FDA 510(k) K000702 · Fresenius Medical Care North America
510(k) numberK000702
Submission
- Device name
- Borla Transducer Protector & Haemotronic Transducer Protector
- Applicant
- Fresenius Medical Care North America
Lexington, MA, US - Received
- March 1, 2000
- Decision date
- June 7, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FIB – Protector, Transducer, Dialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FIB
| 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 |
| 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 |
More from Millipore Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K252181 | AquaAFIP · Traditional | 09/09/2025SE |
| K162488 | Optiflux dialyzerKDI · Traditional | 04/06/2017SE |
| K152953 | Crit-Line Clip (Clic) Blood ChamberKOC · Special | 11/05/2015SE |
| K152367 | Optiflux dialyzerKDI · Traditional | 10/29/2015SE |
| K123262 | Optiflux Ultra DialyzerKDI · Traditional | 01/06/2014SE |
| K131611 | Fresenius Dry Acid Dissolution UnitsKPO · Traditional | 08/29/2013SE |
| K124035 | 2008K@HOME Hemodialysis MachineONW · Traditional | 07/03/2013SE |
| K121341 | Fresenius 2008T Hemodialysis Machine with Bibag SystemKDI · Traditional | 12/06/2012SE |
| K121599 | Crit-Line Clip (Clic)KOC · Traditional | 11/09/2012SE |
| K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag SystemKDI · Special | 02/02/2012SE |
Questions and answers
When was Borla Transducer Protector & Haemotronic Transducer Protector cleared by the FDA?
Borla Transducer Protector & Haemotronic Transducer Protector (K000702) received a 510(k) decision of Substantially Equivalent on June 7, 2000, 98 days after the submission was received.
What is the product code of K000702?
The FDA product code is FIB – Protector, Transducer, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.