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510(k) K873168

SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS by Spectramed, Inc. — Product Code DRS

K873168 is an FDA 510(k) premarket notification submitted by Spectramed, Inc. for the device "SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS". The FDA issued a decision of Substantially Equivalent on January 12, 1988. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Spectramed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1988
Date Received
August 11, 1987
Clearance Type
Traditional
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 Spectramed, Inc.

  • K896122 — AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED (January 19, 1990)
  • K892941 — CCO SYSTEM MODEL SP1467,SP5567,SP6267 (November 6, 1989)
  • K895323 — MODEL DT-BAL, BALANCE SAVER (October 24, 1989)
  • K894362 — MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP (August 15, 1989)
  • K881857 — AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. (February 1, 1989)
  • K885235 — SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. (January 25, 1989)
  • K881825 — MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH (September 28, 1988)
  • K875337 — HEPARIN COATED LUMINAL PACING CATHETER (May 25, 1988)
  • K880740 — MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE (March 22, 1988)
  • K871573 — CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS (September 16, 1987)

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)

FDA data resources