REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10— 510(k) K092425
Substantially EquivalentAscent Healthcare Solutions
FDA 510(k) clearance K092425 for REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10, Substantially Equivalent on 2009-10-21. 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
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- 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.