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510(k) K022570

MEDCOMP REPAIR KIT, MODEL ASPCRPK by Medcomp — Product Code NFK

K022570 is an FDA 510(k) premarket notification submitted by Medcomp for the device "MEDCOMP REPAIR KIT, MODEL ASPCRPK". The FDA issued a decision of Substantially Equivalent on October 31, 2002. The device falls under product code NFK (Kit, Repair, Catheter, Hemodialysis), a Class II device regulated under 21 CFR 876.5540. Medcomp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2002
Date Received
August 2, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Repair, Catheter, Hemodialysis
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Hemodialysis Tray

Other clearances by Medcomp

  • K130889 — SPLIT CATH RG (April 28, 2014)
  • K123292 — T3 (June 11, 2013)
  • K102966 — 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC (December 21, 2010)
  • K091954 — MICRO-STICK SET (January 8, 2010)
  • K091953 — PRO-PICC (September 16, 2009)
  • K092347 — PRO-PICC CT (September 16, 2009)
  • K090394 — VALVED TEARWAY INTRODUCER (September 1, 2009)
  • K091586 — VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN (July 23, 2009)
  • K091466 — 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 (June 17, 2009)
  • K081775 — THE MEDCOMP .010 VASCULAR GUIDEWIRES (March 25, 2009)

Other clearances for product code NFK

  • K101261 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (July 29, 2010)
  • K092797 — ACUTE AND CHRONIC CATHETER REPAIR KIT (November 19, 2009)
  • K063446 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (December 15, 2006)
  • K062435 — REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS (December 5, 2006)
  • K030442 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (July 21, 2003)
  • K022644 — RETRO REPAIR KIT, MODEL PRRK5 (November 6, 2002)
  • K022561 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (August 23, 2002)
  • K020430 — DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) (May 9, 2002)
  • K011015 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (June 22, 2001)
  • K011576 — MEDCOMP ASH SPLIT (June 21, 2001)

FDA data resources