510(k) K221491
K221491 is an FDA 510(k) premarket notification submitted by Apmtd, Inc. for the device "Anivia SG1000 Pump Console". The FDA issued a decision of Substantially Equivalent on February 3, 2023. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Apmtd, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2023
- Date Received
- May 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, Pump Speed, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4380
- Review Panel
- CV
- Submission Type