FDA 510(k)

BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL

K-Number: K961039 · 1996-09-12

Decision Date1996-09-12

Product CodeFJI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL is the device name listed in this FDA 510(k) record. The listed applicant is Dayspring Medical, Inc.. It received FDA 510(k) clearance on 1996-09-12 under 510(k) number K961039. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL?

BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL is a medical device that received FDA 510(k) clearance on 1996-09-12. The listed applicant is Dayspring Medical, Inc.. The 510(k) number is K961039.

When did BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL receive FDA 510(k) clearance?

BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL received FDA 510(k) clearance on 1996-09-12, under 510(k) number K961039.

Who is the listed applicant for BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL?

The FDA 510(k) record lists Dayspring Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL?

The FDA product code for BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL is FJI.

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Other records listing Dayspring Medical, Inc. as applicant

K991005VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS K991003PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI K961040BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC K961026BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL

Related Devices (Code: FJI)

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC K122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical Corporation K043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal Products K010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.