Data / Medical devices / United States / Apmtd, Inc.
Apmtd, Inc.: FDA-registered device maker in Wilmington, MA, United States, 2 510(k) clearances
Apmtd, Inc. is registered with the FDA (registration 3015431638) in Wilmington, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 18, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015431638
- Address
- 226 Lowell Street Unit B16, Wilmington, MA, United States, 01887
- Owner or operator
- APMTD, Inc. (10060044)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 14, 2023
- Registered through
- 2026
- Brand names listed
- Anivia SG1000 Pump Console, Anivia SG1000 Pump Console - Backup Battery Module, Anivia SG1000 Pump Console - Cart Module, Anivia SG1000 Pump Console - Display and Control Module, Anivia SG1000 Pump Console - Flow Bubble Sensor, Anivia SG1000 Pump Console - Pump Driver Module, Anivia SG1000 Pump Console Level Sensor Module
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | DTW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 18, 2023 | K230698 | Anivia SG1000 Pump Console | DWA | Substantially Equivalent | Apmtd, Inc. | accessdata.fda.gov |
| February 3, 2023 | K221491 | Anivia SG1000 Pump Console | DWA | Substantially Equivalent | Apmtd, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Control, Pump Speed, Cardiopulmonary Bypass
- All makers of Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Updated April 18, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.