REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER— 510(k) K063076
Substantially EquivalentAscent Healthcare Solutions
FDA 510(k) clearance K063076 for REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER, Substantially Equivalent on 2007-03-29. Applicant: Ascent Healthcare Solutions. Device class: 2.
Clearance details
- Applicant
- Ascent Healthcare Solutions
- Product code
- Code OWQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, US
Recent devices under product code OWQ
view all- K254149 — Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825) +3 more
- K250545 — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
- K250592 — NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
- K243101 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ) +1 more
- K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936) +1 more
More clearances from Ascent Healthcare Solutions
view all- K111600 — REPROCESSED HAND ACTIVATE SEALER/DIVIDER
- K110189 — REPROCESSED ELECTROSURGICAL INSTRUMENT
- K100909 — REPROCESSED COMPRESSION SLEEVES
- K100254 — REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
- K100537 — REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
Data sourced from openFDA. This site is unofficial and independent of the FDA.