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510(k) K011576

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

K011576 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "MEDCOMP ASH SPLIT". The FDA issued a decision of Substantially Equivalent on June 21, 2001. The device falls under product code NFK (Kit, Repair, Catheter, Hemodialysis), a Class II device regulated under 21 CFR 876.5540. Medical Components, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Medical Components, Inc.

  • K250836 — 14F Duo-Flow® Side X Side Double Lumen Catheter (August 12, 2025)
  • K141633 — PRO-PICC WITH VALVE TECHNOLOGY (September 29, 2014)
  • K132880 — MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE (January 8, 2014)
  • 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)

FDA data resources