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510(k) K972762

CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES by Cardio Metrics, Inc. — Product Code DQX

K972762 is an FDA 510(k) premarket notification submitted by Cardio Metrics, Inc. for the device "CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES". The FDA issued a decision of Substantially Equivalent on October 14, 1997. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Cardio Metrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1997
Date Received
July 24, 1997
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 Cardio Metrics, Inc.

  • K965140 — CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM (August 18, 1997)
  • K951567 — CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE (October 25, 1996)
  • K961777 — ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 (July 31, 1996)
  • K955551 — CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 (February 28, 1996)
  • K954913 — CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) (November 7, 1995)
  • K952562 — CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (August 29, 1995)
  • K943022 — CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE (September 19, 1994)
  • K940984 — CARDIOMETRICS DUALFLOW SWITCH BOX (August 18, 1994)
  • K933320 — CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT (August 17, 1994)
  • K941485 — CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES (May 31, 1994)

Other clearances for product code DQX

  • K253146 — Hyperdrive 35 Guidewire (September 18, 2026)
  • K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 (September 3, 2026)
  • 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)

FDA data resources