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510(k) K941283

INNERSENSE DISPOSABLE MICROTRANSDUCER by Becton Dickinson Vascular Access, Inc. — Product Code DXO

K941283 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vascular Access, Inc. for the device "INNERSENSE DISPOSABLE MICROTRANSDUCER". The FDA issued a decision of Substantially Equivalent on April 19, 1994. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Becton Dickinson Vascular Access, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1994
Date Received
March 17, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Catheter Tip
Device Class
Class II
Regulation Number
870.2870
Review Panel
CV
Submission Type

Other clearances by Becton Dickinson Vascular Access, Inc.

  • K971339 — INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS (December 24, 1997)
  • K970259 — E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET (April 8, 1997)
  • K964049 — FIRST MIDCATH CATHETER WITH DUAL LUMENS (January 6, 1997)
  • K964050 — FIRST MIDCATH CATHETER (January 6, 1997)
  • K964048 — FIRST MIDCATH CATHETER KIT (January 6, 1997)
  • K954906 — FIRST PICC INTRODUCER CATHETER (April 8, 1996)
  • K952861 — ANGIOCATH & INSYTE AUTOGUARD CATHETERS (July 31, 1995)
  • K952757 — ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE C (July 31, 1995)
  • K952053 — E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS (May 31, 1995)
  • K950301 — ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS (April 18, 1995)

Other clearances for product code DXO

  • K251367 — OptoMonitor 3 (January 16, 2026)
  • K241418 — OptoMonitor 3 (February 12, 2025)
  • K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (July 17, 2024)
  • K222216 — TruWave Disposable Pressure Transducer (December 22, 2022)
  • K202943 — OptoMonitor 3 (November 24, 2020)
  • K193620 — OptoMonitor 3 (June 18, 2020)
  • K193279 — Comet II Pressure Guidewire (December 23, 2019)
  • K192340 — OptoMonitor (December 12, 2019)
  • K190852 — Zurich Pressure Guidewire System Model 100 (August 14, 2019)
  • K183413 — TruWave Disposable Pressure Transducer (May 1, 2019)

FDA data resources