Medisystems Tranducer Protector
FDA 510(k) K970536 · Medisystems Corp.
510(k) numberK970536
Submission
- Device name
- Medisystems Tranducer Protector
- Applicant
- Medisystems Corp.
Seattle, WA, US - Received
- February 12, 1997
- Decision date
- May 12, 1997
- 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 |
| 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 |
| K934069 | Millex, Dualex (Plus, Ultra)FIB · Traditional | Millipore Corp. | 04/21/1994SE |
More from Millipore Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K062953 | Medisystems Arterial-Venous Fistula Needle Set with Securement DeviceFIE · Traditional | 02/12/2007SE |
| K010279 | Medisystems Luer Access Injection SiteFPA · Traditional | 05/29/2001SE |
| K002372 | Access Alert GaugeKOC · Traditional | 10/25/2000SE |
| K994306 | ReversoKOC · Traditional | 03/20/2000SE |
| K990803 | Medisystems Buttonhole Needle SetsFIE · Traditional | 01/06/2000SE |
| K983076 | Medisystems Transducer ProtectorFIB · Traditional | 11/25/1998SE |
| K971860 | Medisystems Dialysis Priming SetsKOC · Traditional | 08/18/1997SE |
| K963668 | Medisystems Peritoneal Dialysis SetsKDJ · Traditional | 08/15/1997SE |
| K953823 | Arterial Venous Blood Tubing SetFJK · Traditional | 09/23/1996SE |
| K932074 | Medisystems Apheresis Needle with GuardFIE · Traditional | 02/18/1994SE |
Questions and answers
When was Medisystems Tranducer Protector cleared by the FDA?
Medisystems Tranducer Protector (K970536) received a 510(k) decision of Substantially Equivalent on May 12, 1997, 89 days after the submission was received.
What is the product code of K970536?
The FDA product code is FIB – Protector, Transducer, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.