Clearance Summary
R-GROUP INTL. ONE WALL PUNCTURE NEEDLE received FDA 510(k) clearance under submission number K913267, sponsored by R-Group Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1992-06-05.
- Submission: K913267
- Applicant / Sponsor: R-Group Intl.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1390
- Decision date: 1992-06-05
Classification & Regulation
This clearance is catalogued under FDA product code DRC and 21 CFR 870.1390, within the Cardiovascular review panel as a Class II device.