Clearance Summary
ADAPTING SLEEVE KIT MODEL 4023 received FDA 510(k) clearance under submission number K921318, sponsored by Siemens-Pacesetter, 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 1992-08-03.
- Submission: K921318
- Applicant / Sponsor: Siemens-Pacesetter, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3620
- Decision date: 1992-08-03
Classification & Regulation
This clearance is catalogued under FDA product code DTD and 21 CFR 870.3620, within the Cardiovascular review panel as a Class II device.