Home / 510(k) Clearances / K942066

510(k) K942066

ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE by Advanced Cardiovascular Systems, Inc. — Product Code DQX

K942066 is an FDA 510(k) premarket notification submitted by Advanced Cardiovascular Systems, Inc. for the device "ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on July 18, 1994. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Advanced Cardiovascular Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1994
Date Received
April 29, 1994
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)
  • 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 DQX

  • K253667 — Accoat Guide Wire (July 14, 2026)
  • K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire (July 13, 2026)
  • K254137 — InQwire Amplatz Guide Wire (May 22, 2026)
  • K260544 — FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40 (March 20, 2026)
  • K253746 — Enroute 0.014'' Transcarotid Guidewire (March 19, 2026)
  • K253262 — EmeryGlide™ (EG18008901) (March 6, 2026)
  • K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (January 31, 2026)
  • K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQ (January 21, 2026)
  • K252674 — Solo Pace Fusion System (SOLOFUSE1) (January 9, 2026)
  • K251596 — Lunderquist Extra Stiff Wire Guide (November 9, 2025)

FDA data resources