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510(k) K981667

HYDROPHILIC COATED GUIDEWIRE by Lake Region Mfg., Inc. — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1998
Date Received
May 11, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Lake Region Mfg., Inc.

  • K092965 — TRAILRUNNER GUIDEWIRES (February 26, 2010)
  • K082922 — FREEWAY AND RAILRUNNER GUIDEWIRES (December 9, 2008)
  • K081708 — TAXI ENDOSCOPIC GUIDEWIRE (August 26, 2008)
  • K080144 — MANDREL GUIDEWIRES OR M-WIRES (February 26, 2008)
  • K073655 — PEGASUS STEERABLE (PTCA) GUIDEWIRE (January 28, 2008)
  • K060454 — TITAN GUIDEWIRE (March 24, 2006)
  • K052347 — TITAN STEERABLE (PTCA) GUIDEWIRE (February 17, 2006)
  • K042338 — CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE (September 16, 2004)
  • K041624 — PTCA STEERABLE HYDROPHILIC GUIDEWIRE (July 16, 2004)
  • K040825 — LAKE REGION HYDROPHILIC GUIDEWIRE (May 17, 2004)

Other clearances for product code KNY

  • K182144 — Bi-Flex Evo (September 7, 2018)
  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • K140441 — BI-FLEX URETERAL ACCESS SHEATH (June 17, 2014)
  • K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE (June 16, 2014)
  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)
  • K131803 — GUARDIAN URETHRAL SHEATH (August 20, 2013)
  • K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH (February 4, 2013)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)
  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)
  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)