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510(k) K942382

MS AMPLATZ EXTRA STIFF GUIDE WIRE by Meadox Surgimed, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1994
Date Received
May 19, 1994
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.

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  • K945061 — NOPROFILE OLBERT CATHETER SYSTEM (March 9, 1995)
  • 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)
  • K904582 — QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE (February 25, 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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