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510(k) K963702

ACS HI-TORQUE IRON MAN GUIDE WIRE by Advanced Cardiovascular Systems, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1997
Date Received
September 16, 1996
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 Advanced Cardiovascular Systems, Inc.

  • K012534 — HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (January 24, 2002)
  • K000550 — OTW MEGALINK SDS BILIARY STENT SYSTEM (March 17, 2000)
  • K994229 — VERIPATH PERIPHERAL GUIDING CATHETER (February 25, 2000)
  • K992169 — ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE (October 28, 1999)
  • K990867 — RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,100 (September 2, 1999)
  • K962495 — INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC (September 12, 1996)
  • K961471 — INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 (May 8, 1996)
  • K955175 — ACS ANCHOR EXCHANGE DEVICE (April 5, 1996)
  • K953987 — ACS TOURGIDE GUIDING CATHETER (December 7, 1995)
  • K952205 — ACS POWERBASE GUILDING CATHETER (August 4, 1995)

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