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510(k) K102033

COMBITRANS MONITORING SETS AND ACCESSORIES by B.Braun Melsungen AG — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2011
Date Received
July 19, 2010
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type

Other clearances by B.Braun Melsungen AG

  • K163358 — Introcan Safety 3 Closed IV Catheter (April 28, 2017)
  • K152050 — Pencylcap (March 2, 2016)
  • K131040 — EXTAVIPRO STERICAN 30G (July 15, 2013)
  • K111236 — INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (3 (August 30, 2011)

Other clearances for product code DRS

  • K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (March 21, 2025)
  • K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes (March 17, 2023)
  • K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw (November 9, 2017)
  • K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw (May 24, 2017)
  • K161408 — Compass Cast and MAP (November 22, 2016)
  • K152472 — Disposable Pressure Transducer (October 31, 2016)
  • K152980 — Flo Trac sensor, Volume View sensor (January 19, 2016)
  • K151040 — Art-line Single channel blood pressure system, Art-line Double channel blood pre (September 4, 2015)
  • K133624 — COMPASS CT, COMPASS CT PORT (April 18, 2014)
  • K123095 — MEDLINE BLOOD PRESSURE TRANSDUCER (May 8, 2013)