Clearance Summary
TRANS-CATHETER EXTRACTOR received FDA 510(k) clearance under submission number K063048, sponsored by Tran Pa-C, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2007-09-14.
- Submission: K063048
- Applicant / Sponsor: Tran Pa-C, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 2007-09-14
Classification & Regulation
This clearance is catalogued under FDA product code ODY and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.