Dialysis Trandsducer Protector

FDA 510(k) K911658 · Tico Medical Instruments, Inc.

Substantially Equivalent

510(k) numberK911658

Submission

Device name
Dialysis Trandsducer Protector
Applicant
Tico Medical Instruments, Inc.
Cocoa, FL, US
Received
April 12, 1991
Decision date
August 12, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

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)DeviceApplicantDecision
K240164NovaLine SP-C35 Transducer Protector (956007)FIB · Traditional Bain Medical Equipment (Guangzhou) Co., Ltd.06/28/2024SE
K072988Nipro Transducer Protector Tp-Sure, Model TPSURE+1FIB · Traditional Nipro Medical Corporation02/21/2008SE
K001971Hemodialysis Tubing SetsFIB · Traditional Ofi Biomedica S.P.A.05/24/2001SE
K010264Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming SetFIB · Traditional Nipro Medical Corp.04/27/2001SE
K001465Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming SetFIB · Traditional Nipro Medical Corp.12/05/2000SE
K003445Fresenius Viral Blocking Transducer Protector for Hemodialysis, Model 04-9500-2FIB · Special Fresenius Medical Care North America12/01/2000SE
K000702Borla Transducer Protector & Haemotronic Transducer ProtectorFIB · Traditional Fresenius Medical Care North America06/07/2000SE
K983076Medisystems Transducer ProtectorFIB · Traditional Medisystems Corp.11/25/1998SE
K964337Better-Bladder (BB)FIB · Traditional Circulatory Technology, Inc.05/23/1997SE
K970536Medisystems Tranducer ProtectorFIB · Traditional Medisystems Corp.05/12/1997SE

More from Medisystems Corp.

510(k)DeviceDecision
K884938Vital Signs MonitorDSK · Traditional 04/19/1989SE
K842985T- Extension Set T-04-CFPA · Traditional 08/07/1984SE
K840443Retrograde Infusion Set 3ML & 6ML-FPA · Traditional 04/17/1984SE

Questions and answers

When was Dialysis Trandsducer Protector cleared by the FDA?

Dialysis Trandsducer Protector (K911658) received a 510(k) decision of Substantially Equivalent on August 12, 1991, 122 days after the submission was received.

What is the product code of K911658?

The FDA product code is FIB – Protector, Transducer, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.