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510(k) K011084

MANDREL GUIDEWIRE ASSEMBLY by Lake Region Mfg., Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2001
Date Received
April 10, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
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)

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