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510(k) K904582

QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE by Meadox Surgimed, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1991
Date Received
October 9, 1990
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 Meadox Surgimed, Inc.

  • K944143 — MS CLASSIQUE BALLOON CATHETER (March 13, 1995)
  • K945061 — NOPROFILE OLBERT CATHETER SYSTEM (March 9, 1995)
  • K942382 — MS AMPLATZ EXTRA STIFF GUIDE WIRE (August 22, 1994)
  • K930201 — ACECUT SUTOMATIC BIOPSY SYSTEM (June 9, 1993)
  • K911635 — MEADOX(R) SURGIMED(R) BIOPSY GUN II (June 20, 1991)
  • K905181 — NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY (March 6, 1991)
  • K904983 — MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY (January 30, 1991)
  • K902461 — MEADOX SURGIMED BIOPSY GUN AND NEEDLE (July 16, 1990)
  • K890926 — SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE (June 20, 1989)
  • K863218 — CYTOSTATIC FILTRATION SET (February 12, 1987)

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