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510(k) K895899

FLEXMEDICS GUIDEWIRE .012 ONLY by Flexmedics — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1990
Date Received
October 6, 1989
Clearance Type
Traditional
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 Flexmedics

  • K990765 — FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GU (March 15, 1999)
  • K964955 — FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWI (February 14, 1997)
  • K952430 — FINESSE GUIDEWIRE CORONARY (August 18, 1995)
  • K943390 — FLEXFINDER GUIDEWIRE (June 27, 1995)
  • K942074 — FLEXFINDER GUIDEWIRE (June 24, 1994)
  • K934265 — FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE (January 21, 1994)
  • K912843 — FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (September 24, 1991)
  • K910674 — FLEXMEDICS MALLEABLE CANNULA (April 12, 1991)
  • K893626 — FLEXMEDICS GUIDEWIRE (September 26, 1989)
  • K885086 — TIN COATED NITI ORTHODONTIC ARCH WIRES (January 10, 1989)

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