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510(k) K073664

FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER by Injectimed, Inc. — Product Code MDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2008
Date Received
December 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Injectimed, Inc.

  • K040029 — SAFETYNET GUIDEWIRE INTRODUCER (April 5, 2004)
  • K922158 — PROTECTOR SYRINGE SAFETY CAP SYSTEM (July 21, 1992)

Other clearances for product code MDM

  • K050575 — FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM (August 15, 2005)
  • K050957 — EUTROCHAR (May 18, 2005)
  • K023173 — ANDREWS INTRODUCER, MODEL ASI01 (December 18, 2002)
  • K022059 — MICROVASIVE PULMONARY GUIDEWIRE (November 13, 2002)
  • K013040 — LIGHT SABER INTRODUCER NEEDLE (December 7, 2001)
  • K010184 — CHESS HAND SURGERY SYSTEM (June 22, 2001)
  • K990062 — SAPHLIFT (March 30, 1999)
  • K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (July 9, 1998)
  • K943968 — TUNNELER (March 1, 1995)
  • K945430 — DERMAVBLADE(TM) (November 28, 1994)