K232037
- 510(k) number
- K232037
- Device name
- Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
- Applicant
- Innovative Health, LLC AZ · US
- Product code
- PNE — Reprocessed Catheter Introducer
- Decision date
- 2024-04-04
- Date received
- 2023-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232037.pdf
Official FDA record: K232037
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.