K231015
- 510(k) number
- K231015
- Device name
- Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
- Applicant
- Innovative Health, LLC AZ · US
- Product code
- NLI — Catheter, Angiography, Reprocessed
- Decision date
- 2024-07-01
- Date received
- 2023-04-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K231015.pdf
Official FDA record: K231015
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.