Home / 510(k) Clearances / K132730

510(k) K132730

BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE by Medtronic, Inc. — Product Code DPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2014
Date Received
September 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Medtronic, Inc.

  • K253203 — Retrograde Coronary Sinus Perfusion Cannulae (February 19, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K251744 — Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Ar (January 16, 2026)
  • K251831 — Bio-Medicus Life Support Catheter and Introducer (January 15, 2026)
  • K253511 — Concerto Versa™ Detachable Coil (January 14, 2026)
  • K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320 (December 19, 2025)
  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
  • K250075 — Medtronic Stedi Extra Support Guidewire (June 13, 2025)
  • K250199 — VitalFlow Console (May 20, 2025)
  • K250558 — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) (March 27, 2025)

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)
  • 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)
  • K121429 — AIMAGO EASYLDI MICROCIRCULATION CAMERA (August 10, 2012)