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510(k) K961039

Device
BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL
Applicant
DAYSPRING MEDICAL, INC.
510(k) number
K961039
Product code
FJI  
Decision
Substantially Equivalent (SESE)
Decision date
1996-09-12
Date received
1996-03-14
Regulation
876.5820
Classification name
Dialyzer, Capillary, Hollow Fiber
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
NEIL RASMUSSEN
Address
1936 Beacon Ct. Boulder CO US 80302 80302

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FJI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC2019-08-23
K122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical Corporation2013-12-04
K043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal Products2005-05-27
K010366DISPOSABLE STORAGE CAPMolded Products, Inc.2001-11-28
K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.2001-06-13
K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America2000-12-04
K991908IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERSIdemsa2000-04-17
K992594A-15 HEMODIALYZERAlthin Medical AB1999-09-24
K992565A-18 HEMODIALYZERAlthin Medical AB1999-09-23
K991512ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-XAsahi Medical Co., Ltd.1999-07-29
K990159DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111Dynamic Technology Corp.1999-04-19
K982337CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZERHaidylena Medical Egypt1998-12-29
K981253ULTRACON ULTRAFILTRATORInterpore Intl.1998-12-11
K980658PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234Baxter Healthcare Corp1998-05-19
K971710ULTRACON ULTRAFILTRATORQuantic Biomedical, Inc.1998-02-27

Legacy Summary#

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FDA Review#

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