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510(k) K002958

SHAPEABLE DOPPLER FLOW PROBE by Cook Vascular, Inc. — Product Code ITX

K002958 is an FDA 510(k) premarket notification submitted by Cook Vascular, Inc. for the device "SHAPEABLE DOPPLER FLOW PROBE". The FDA issued a decision of Substantially Equivalent on December 18, 2001. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Cook Vascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2001
Date Received
September 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Cook Vascular, Inc.

  • K142301 — Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sh (November 12, 2014)
  • K141148 — EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTRO (July 1, 2014)
  • K110347 — DOPPLER MONITOR (March 16, 2011)
  • K083482 — COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET (April 2, 2009)
  • K081425 — COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT (September 30, 2008)
  • K061000 — EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 (May 10, 2006)
  • K032223 — COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT (October 15, 2003)
  • K023937 — COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM (May 27, 2003)
  • K022649 — COOK-SWARTZ DOPPLER FLOW PROBE (September 6, 2002)
  • K010128 — COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE (April 25, 2002)

Other clearances for product code ITX

  • K261170 — BA-004CC (August 12, 2026)
  • K254143 — EM-TECH Passive Ultrasound Probe Strap (August 10, 2026)
  • K260161 — SmartGuide Disposable Guides and Grids (July 30, 2026)
  • K262474 — ND Needle Guidance System (July 27, 2026)
  • K261014 — Accuro® 3S Needle Guide Kit (July 24, 2026)
  • K250883 — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) (September 18, 2025)
  • K250762 — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20 (July 11, 2025)
  • K250524 — Mendaera Guidance System (July 2, 2025)
  • K250469 — Accuro® 3S Needle Guide Kit (June 13, 2025)
  • K241662 — Ultrasound Transducer Cover (August 30, 2024)

FDA data resources