K242225
- 510(k) number
- K242225
- Device name
- Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
- Applicant
- Surgical Instrument Service and Savings, Inc. OR · US
- Product code
- NLH — Catheter, Recording, Electrode, Reprocessed
- Decision date
- 2024-11-29
- Date received
- 2024-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242225.pdf
Official FDA record: K242225
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.