Clearance Summary
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 received FDA 510(k) clearance under submission number K033424, sponsored by Transonic Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-12-11.
- Submission: K033424
- Applicant / Sponsor: Transonic Systems, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2100
- Decision date: 2003-12-11
Classification & Regulation
This clearance is catalogued under FDA product code DPW and 21 CFR 870.2100, within the Cardiovascular review panel as a Class II device.