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510(k) K023024

TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 by Vascular Control Systems, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2002
Date Received
September 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Vascular Control Systems, Inc.

  • K060573 — BURBANK TENACULUM (April 21, 2006)
  • K052209 — VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 (September 6, 2005)
  • K032125 — CSTAT, MODELS 09-0014-01 AND 09-0014-02 (February 9, 2004)
  • K031812 — TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 (December 12, 2003)
  • K031358 — TRANSVAGINAL DOPPLER PROBE (May 9, 2003)
  • K030078 — BURBANK TENACULUM, MODEL 09-0011-01 (January 24, 2003)
  • K023154 — VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 (December 20, 2002)
  • K011863 — VCS-A SERIES CLAMP (February 15, 2002)

Other clearances for product code ITX

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  • K250524 — Mendaera Guidance System (July 2, 2025)
  • K250469 — Accuro® 3S Needle Guide Kit (June 13, 2025)
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  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K241615 — Transducer Probe Cover (July 3, 2024)
  • K233109 — TP Pivot Pro™ Needle Guide (December 22, 2023)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231783 — VitroPRO (November 14, 2023)