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510(k) K812130

SPIKE GUARD by Clinipad Corp. — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1981
Date Received
July 27, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Clinipad Corp.

  • K931560 — CARDIAC CATHETERIZATION TRAY (July 11, 1994)
  • K931668 — PICC INSERTION TRAY (March 7, 1994)
  • K932071 — I.V. START KIT (February 17, 1994)
  • K932010 — V.A.D. ACCESS KIT (February 3, 1994)
  • K932036 — LACERATION TRAY (December 13, 1993)
  • K932016 — TRACHEOSTOMY CARE TRAY (November 3, 1993)
  • K862562 — PUNCH BIOPSY KIT (October 7, 1986)
  • K862563 — TRACHEOSTOMY CLEANSING SOLUTION (July 15, 1986)
  • K833075 — WET DRESSING KIT (January 27, 1984)
  • K833432 — CATHETER INSERTION KIT (December 28, 1983)

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  • K214016 — 15L Cycler Drainage Bag (March 18, 2022)
  • K192705 — MiniCap Extended Life PD Transfer Sets (October 25, 2019)
  • K173593 — stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter ext (May 21, 2018)
  • K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (February 14, 2018)
  • K173363 — Cycler Drain Bag Set (January 24, 2018)
  • K151620 — Firefly Peritoneal Dialysis Connector Disinfection System (January 20, 2016)
  • K152129 — FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iod (October 29, 2015)
  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (October 29, 2015)