Home / 510(k) Clearances / K052209

510(k) K052209

VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 by Vascular Control Systems, Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2005
Date Received
August 15, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

Other clearances by Vascular Control Systems, Inc.

  • K060573 — BURBANK TENACULUM (April 21, 2006)
  • 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)
  • K023024 — TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 (September 26, 2002)
  • K011863 — VCS-A SERIES CLAMP (February 15, 2002)

Other clearances for product code DPW

  • K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speake (November 20, 2025)
  • K251114 — FloPatch FP120 (June 20, 2025)
  • K243852 — Elfor-L (April 14, 2025)
  • K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
  • K223843 — FloPatch FP120 (May 3, 2023)
  • K222242 — FloPatch FP120 (December 9, 2022)
  • K213974 — GEM FLOW COUPLER Monitor (GEM1020M-2) (April 20, 2022)
  • K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)
  • K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (October 7, 2021)
  • K201114 — Bidop 7 (January 5, 2021)