VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS

K Number: K991005 · Decision Jun 22, 1999

Classifications

FEI Numbers

Registration Numbers

Same Product Code

Applicant Total

Review Days

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Device Name: VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS
K Number: K991005
Device Class: FDA class 2
Clearance Type: Traditional
Regulation Number: 876.5820
Medical Specialty: Gastroenterology, Urology
Decision: Substantially Equivalent
Statement or Summary: Statement
Applicant: Dayspring Medical, Inc.
Date Received: March 25, 1999
Decision Date: June 22, 1999
Product Code: LLB
Advisory Committee: Gastroenterology, Urology
Review Advisory Committee: GU
Third Party: N

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
LLB	System, Blood, Extracorporeal And Accessories	FDA class 2	Gastroenterology, Urology

Other 510(k) clearances with the same product code (LLB), ordered by most recent decision date.

View all

K Number	Device Name	Decision Date	Decision
K991003	PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI	Jun 9, 1999	Substantially Equivalent
K961039	BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL	Sep 12, 1996	Substantially Equivalent
K961040	BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC	Jun 11, 1996	Substantially Equivalent
K961026	BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL	Jun 10, 1996	Substantially Equivalent