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510(k) K863969

CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D by Camino Laboratories, Inc. — Product Code DXO

K863969 is an FDA 510(k) premarket notification submitted by Camino Laboratories, Inc. for the device "CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D". The FDA issued a decision of Substantially Equivalent on May 27, 1987. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Camino Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1987
Date Received
October 14, 1986
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 Camino Laboratories, Inc.

  • K932769 — CAMINO VENTRICULAR DRAINAGE SYSTEM (March 30, 1995)
  • K930222 — CAMINO VENTRICULAR ACCESS DEVICE (April 15, 1993)
  • K930221 — CAMINO VENTRICULAR TRANSDUCER ACCESSORY (April 15, 1993)
  • K920088 — CAMINO VENTRICULAR NEEDLE (May 1, 1992)
  • K914735 — VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM (January 17, 1992)
  • K912833 — CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY (September 23, 1991)
  • K893232 — MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM (July 14, 1989)
  • K881183 — VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H (May 4, 1988)
  • K861961 — CAMINO CSF DRAINAGE SYSTEM MODEL 040 (August 12, 1986)
  • K862160 — CAMINO HAND DRILL - MODEL 030 (July 18, 1986)

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