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510(k) K212065

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger by Remington Medical, Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2021
Date Received
July 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Remington Medical, Inc.

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  • K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
  • K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)
  • K191315 — Remington Medical, Inc. Automatic Cutting Needle (NAC) (July 12, 2019)
  • K150266 — Remington Medical Inc. Tuohy Epidural Needles (June 4, 2015)
  • K130282 — REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT (May 13, 2013)
  • K050884 — ADAPTER CABLE (May 19, 2005)
  • K040266 — CORE NEEDLE BIOPSY (July 9, 2004)
  • K990428 — DRAINAGE BAG (August 12, 1999)
  • K983621 — NEEDLE GUIDE (November 3, 1998)

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)
  • K201114 — Bidop 7 (January 5, 2021)
  • K200337 — FloPatch (FP120) (March 24, 2020)