REPROCESSED ELECTROPHYSIOLOGY CATHETERS— 510(k) K090323
Substantially EquivalentAscent Healthcare Solutions
FDA 510(k) clearance K090323 for REPROCESSED ELECTROPHYSIOLOGY CATHETERS, Substantially Equivalent on 2009-04-01. Applicant: Ascent Healthcare Solutions. Device class: 2.
Clearance details
- Applicant
- Ascent Healthcare Solutions
- Product code
- Code NLH
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, US
Recent devices under product code NLH
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- K250772 — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
- K242225 — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
- K241224 — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
- K240826 — Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
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.