Home / 510(k) Clearances / K022620

510(k) K022620

SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT by Spire Biomedical, Inc. — Product Code FKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2002
Date Received
August 7, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Spire Biomedical, Inc.

  • K073092 — DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, (January 29, 2008)
  • K073093 — DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC1 (January 22, 2008)
  • K063441 — 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC2 (February 12, 2007)
  • K063431 — 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DF (January 29, 2007)
  • K062435 — REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS (December 5, 2006)
  • K060288 — RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS (September 1, 2006)
  • K060155 — 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED (May 9, 2006)
  • K042858 — 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS (December 3, 2004)
  • K041559 — 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,R (July 30, 2004)
  • K040509 — ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27 (April 19, 2004)

Other clearances for product code FKA

  • K914210 — VAS-CATH DUALATOR(TM) VESSEL DILATOR (July 1, 1993)
  • K910502 — VESSEL DILATORS (April 29, 1991)