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510(k) K991003

PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI by Dayspring Medical, Inc. — Product Code FKY

K991003 is an FDA 510(k) premarket notification submitted by Dayspring Medical, Inc. for the device "PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI". The FDA issued a decision of Substantially Equivalent on June 9, 1999. The device falls under product code FKY (Connector, Tubing, Dialysate), 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 9, 1999
Date Received
March 25, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Tubing, Dialysate
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Dayspring Medical, Inc.

  • K991005 — VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC10 (June 22, 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 FKY

  • K862722 — TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE (August 11, 1986)
  • K830002 — CAPD COLOR-GUARD SYSTEM PREPKIT (March 11, 1983)
  • K771428 — TENCKHOFF PERITONEAL TUBING ADAPT. (October 18, 1977)

FDA data resources