Home / 510(k) Clearances / K063076

510(k) K063076

REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER by Ascent Healthcare Solutions — Product Code OWQ

K063076 is an FDA 510(k) premarket notification submitted by Ascent Healthcare Solutions for the device "REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER". The FDA issued a decision of Substantially Equivalent on March 29, 2007. The device falls under product code OWQ (Reprocessed Intravascular Ultrasound Catheter), a Class II device regulated under 21 CFR 870.1200. Ascent Healthcare Solutions has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2007
Date Received
October 6, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reprocessed Intravascular Ultrasound Catheter
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

Other clearances by Ascent Healthcare Solutions

  • K111600 — REPROCESSED HAND ACTIVATE SEALER/DIVIDER (November 15, 2011)
  • K110189 — REPROCESSED ELECTROSURGICAL INSTRUMENT (July 18, 2011)
  • K100909 — REPROCESSED COMPRESSION SLEEVES (July 23, 2010)
  • K100254 — REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER (May 28, 2010)
  • K100537 — REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FC (May 12, 2010)
  • K100080 — REPROCESSED TROCARS, MODEL B5LT AND CB5LT (March 19, 2010)
  • K093702 — REPROCESSED ULTRASONIC COAGULATING SHEARS (March 4, 2010)
  • K092425 — REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 (October 21, 2009)
  • K090323 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (April 1, 2009)
  • K082023 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (September 16, 2008)

Other clearances for product code OWQ

  • K254149 — Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens S (June 29, 2026)
  • K250545 — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound (June 5, 2025)
  • K250592 — NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (May 12, 2025)
  • K243101 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for S (March 10, 2025)
  • K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Si (September 10, 2024)
  • K232130 — Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter (December 15, 2023)
  • K232584 — Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocesse (October 24, 2023)
  • K230928 — Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter (August 25, 2023)
  • K231621 — Reprocessed ViewFlex Xtra ICE Catheter (D087031) (July 25, 2023)
  • K231588 — ViewFlex™ Eco Reprocessed ICE Catheter (June 30, 2023)

FDA data resources