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1.3 Application Form/Administrative Information
Add ContentRegional cover letter and application form identifying the submission type, device, manufacturer and authorised representative.
This submission concerns the FlexCath Pro Steerable Sheath, a Class III steerable introducer sheath intended for percutaneous transseptal access during cardiac ablation procedures. The legal manufacturer is Meridian Vascular Inc., 1400 Harbor Way, Cleveland OH 44114, USA. The EU Authorised Representative is Meridian Vascular Europe B.V., Amsterdam, Netherlands (SRN NL-AR-000-021-345). This is an initial conformity assessment application under Regulation (EU) 2017/745, Annex IX Chapters I and II. The Basic UDI-DI is 08712345000012XX. No prior CE certificate exists for this device family.
Appendix Documents
Link Document| Rimsys Number | Name | Confidential | Upload Type | Version |
|---|---|---|---|---|
| DOC-0001 | Cover-Letter-FlexCathPro-v3.pdf | No | Cover Letter | v3.0 |
| DOC-0002 | EC-REP-Mandate-Signed.pdf | No | Mandate | v1.0 |