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A.6 Cover Letter
Add ContentCover Letter
Drafted
2026-11-14
YYYY-MM-DD
YYYY-MM-DD
YYYY-MM-DD
BMBruce McKean
Cover letter identifying the submission type, device, submitter and any prior FDA interactions.
Meridian Vascular Inc. respectfully submits this Traditional 510(k) for the FlexCath Pro Steerable Sheath, a single-use steerable introducer sheath intended for percutaneous transseptal access. This submission follows Pre-Submission Q250417, for which FDA feedback was received on 2026-03-02 regarding the adequacy of the bench test matrix. The primary predicate is K221884 (FlexCath Advance Steerable Sheath).
Appendix Documents
Link Document| Rimsys Number | Name | Confidential | Upload Type | Version |
|---|---|---|---|---|
| DOC-0001 | 510k-Cover-Letter-FlexCathPro.pdf | No | Cover Letter | v2.0 |