Clearance Summary
ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER received FDA 510(k) clearance under submission number K141529, sponsored by Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-12-03.
- Submission: K141529
- Applicant / Sponsor: Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2014-12-03
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.