Home / 510(k) Clearances / K991005

510(k) K991005

VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS by Dayspring Medical, Inc. — Product Code LLB

K991005 is an FDA 510(k) premarket notification submitted by Dayspring Medical, Inc. for the device "VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS". The FDA issued a decision of Substantially Equivalent on June 22, 1999. The device falls under product code LLB (System, Blood, Extracorporeal And Accessories), a Class II device regulated under 21 CFR 876.5820. Dayspring Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1999
Date Received
March 25, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Blood, Extracorporeal And Accessories
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Dayspring Medical, Inc.

  • K991003 — PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LO (June 9, 1999)
  • K961039 — BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE V (September 12, 1996)
  • K961040 — BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC (June 11, 1996)
  • K961026 — BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL (June 10, 1996)

Other clearances for product code LLB

  • K831404 — BLOOD MONITOR BMM 10-4 (April 25, 1984)

FDA data resources