510(k) K190282
K190282 is an FDA 510(k) premarket notification submitted by Spectrum Medical , Ltd. for the device "Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)". The FDA issued a decision of Substantially Equivalent on May 24, 2019. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Spectrum Medical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2019
- Date Received
- February 11, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4220
- Review Panel
- CV
- Submission Type