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510(k) K013939

JOSTRA FLOWPROBE FP-32E by Jostra AG — Product Code DPT

K013939 is an FDA 510(k) premarket notification submitted by Jostra AG for the device "JOSTRA FLOWPROBE FP-32E". The FDA issued a decision of Substantially Equivalent on December 14, 2001. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Jostra AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2001
Date Received
November 29, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type

Other clearances by Jostra AG

  • K020983 — JOSTRA SUCKERS, MODEL JS (January 30, 2004)
  • K031544 — HEATER COOLER UNIT, MODEL HCU 30 (August 7, 2003)
  • K030264 — QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 (February 26, 2003)
  • K020784 — JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS (January 9, 2003)
  • K023132 — JOSTRA MECC SYSTEM (December 17, 2002)
  • K022022 — JOSTRA VENT CATHETERS, MODELS LV & HKV (September 11, 2002)
  • K020515 — JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA (April 24, 2002)
  • K014303 — JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE (March 26, 2002)
  • K013944 — JOSTRA DUAL STAGE VENOUS RETURN CANNULAE (February 11, 2002)
  • K012774 — JOSTRA ARTERIAL PERFUSION CANNULAE (November 16, 2001)

Other clearances for product code DPT

  • K233076 — Laser Speckle Imaging System (RFLSI CZW) (May 28, 2024)
  • K163339 — SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 (August 17, 2017)
  • K152749 — moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared (May 12, 2016)
  • K142932 — Deltex Medical KDP72 Doppler Probe (January 22, 2015)
  • K132730 — BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE (May 30, 2014)
  • K133903 — BIO-PROBE TRANSDUCER (ADULT) (April 10, 2014)
  • K132163 — MOORLDLS-BI LASER DOPPLER BURNS IMAGER (January 29, 2014)
  • K124049 — DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM (April 18, 2013)
  • K123216 — AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI (February 7, 2013)
  • K122943 — MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER (January 3, 2013)

FDA data resources