Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set
FDA 510(k) K001465 · Nipro Medical Corp.
510(k) numberK001465
Submission
- Device name
- Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set
- Applicant
- Nipro Medical Corp.
Weston, FL, US - Received
- May 10, 2000
- Decision date
- December 5, 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
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|---|---|---|---|
| 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 |
| 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 |
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| K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleFMI · Traditional | 05/25/2023SE |
| K212677 | aboNT SYRINGEFMF · Traditional | 04/15/2022SE |
| K190037 | Cronus HP PTA Balloon CatheterLIT · Traditional | 10/24/2019SE |
| K191359 | Nipro SyringeFMF · Traditional | 10/09/2019SE |
| K182940 | Surdial DX Hemodialysis SystemKDI · Traditional | 07/19/2019SE |
| K173029 | Nipro SyringeFMF · Traditional | 03/30/2018SE |
| K161681 | Nipro SafeTouch IV CatheterFOZ · Traditional | 03/08/2017SE |
Questions and answers
When was Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set cleared by the FDA?
Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set (K001465) received a 510(k) decision of Substantially Equivalent on December 5, 2000, 209 days after the submission was received.
What is the product code of K001465?
The FDA product code is FIB – Protector, Transducer, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.