K242756
- 510(k) number
- K242756
- Device name
- Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)
- Applicant
- Pulnovo Medical (Wuxi) Co., Ltd. CN
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-11-08
- Date received
- 2024-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242756.pdf
Official FDA record: K242756
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.