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510(k) K841992

MODIFICATION TO ACS CORONARY GUIDING by Advanced Cardiovascular Systems, Inc. — Product Code DAO

K841992 is an FDA 510(k) premarket notification submitted by Advanced Cardiovascular Systems, Inc. for the device "MODIFICATION TO ACS CORONARY GUIDING". The FDA issued a decision of Substantially Equivalent on June 11, 1984. The device falls under product code DAO (Igm (Mu Chain Specific), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Advanced Cardiovascular Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1984
Date Received
April 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm (Mu Chain Specific), Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
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)

Other clearances for product code DAO

  • K040431 — ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 (March 10, 2004)
  • K982639 — SPIFE URINE IFE (November 4, 1998)
  • K955908 — BOEHRINGER MANNHEIM IGM ASSAY (February 9, 1996)
  • K850586 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (March 14, 1985)
  • K812487 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM (September 23, 1981)
  • K800450 — GEMENI IGM ASSAY (April 24, 1980)
  • K790705 — ANTISERUM TO HUMAN IGM (April 12, 1979)

FDA data resources