Clearance Summary
TORFLEX TRANSSEPTAL GUIDING SHEATH received FDA 510(k) clearance under submission number K013919, sponsored by Baylis Medical Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2002-02-22.
- Submission: K013919
- Applicant / Sponsor: Baylis Medical Co., Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5520
- Decision date: 2002-02-22
Classification & Regulation
This clearance is catalogued under FDA product code DBY and 21 CFR 866.5520, within the Immunology review panel as a Class I device.