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510(k) K934009

ACS POWERGUIDE CORONARY GUIDING CATHETER by Advanced Cardiovascular Systems, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1994
Date Received
August 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
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)
  • K963702 — ACS HI-TORQUE IRON MAN GUIDE WIRE (January 22, 1997)
  • 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)

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