FDA.reportPublic FDA data

510(k) K974387

Device
PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
Applicant
MICROWAVE MEDICAL SYSTEMS, INC.
510(k) number
K974387
Product code
KDJ  
Decision
Substantially Equivalent (SESE)
Decision date
1999-09-01
Date received
1997-11-21
Regulation
876.5630
Classification name
Set, Administration, For Peritoneal Dialysis, Disposable
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICHARD S GRABOWY
Address
310-312 School St. Acton MA US 01720 01720

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KDJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250404stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inchFresenius Medical Care Renal Therapies Group, LLC2025-04-03
K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483Baxter Healthcare2024-03-12
K21401615L Cycler Drainage BagBaxter Healthcare Corporation2022-03-18
K192705MiniCap Extended Life PD Transfer SetsBaxter Healthcare2019-10-25
K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inchFresenius Medical Care Renal Therapies Group, LLC2018-05-21
K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLC2018-02-14
K173363Cycler Drain Bag SetFresenius Medical Care Renal Therapies Group, LLC2018-01-24
K151620Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc.2016-01-20
K152129FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine SolutionBaxter Healthcare Corporation2015-10-29
K152675EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTERBaxter Healthcare2015-10-29
K124024APD LUER-LOCK ADAPTERFresensius Medical Care North America2013-09-19
K083542FRESENIUS STERILE STAY SAFE CAPFresenius Medical Care North America2008-12-29
K042900K.E.P. CONNECTOR AND CLIPK.E.P., LLC2004-11-05
K041792FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211Fresenius Medical Care North America2004-09-24
K031676HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599QBaxter Healthcare Corp2003-11-20

Legacy Summary#

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FDA Review#

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