Clearance Summary
MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT received FDA 510(k) clearance under submission number K893436, sponsored by Pioneering Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-07-14.
- Submission: K893436
- Applicant / Sponsor: Pioneering Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4500
- Decision date: 1989-07-14
Classification & Regulation
This clearance is catalogued under FDA product code DWS and 21 CFR 870.4500, within the Cardiovascular review panel as a Class I device.