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510(k) K934624

ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE by Advanced Cardiovascular Systems, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1994
Date Received
September 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Advanced Cardiovascular Systems, Inc.

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  • 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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