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510(k) K011576

MEDCOMP ASH SPLIT by Medical Components, Inc. — Product Code NFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2001
Date Received
May 22, 2001
Clearance Type
Special
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

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  • K131687 — 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET (August 16, 2013)
  • K130687 — 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER (August 15, 2013)
  • K130923 — 5F DIGNITY CT TITANIUM PORT (July 31, 2013)
  • K124046 — VALVED TEARAWAY INTRODUCER GENERATION II (June 3, 2013)
  • K123617 — 3F PRO-PICC (May 15, 2013)
  • K122423 — VASU-PICC (December 12, 2012)
  • K121848 — SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT (September 21, 2012)

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)
  • K022570 — MEDCOMP REPAIR KIT, MODEL ASPCRPK (October 31, 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)