Data / Medical devices / United States / Pleural Dynamics, Inc.
Pleural Dynamics, Inc.: FDA-registered device maker in Minnetonka, MN, United States, 1 510(k) clearance
Pleural Dynamics, Inc. is registered with the FDA (registration 3029300753) in Minnetonka, MN, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 18, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029300753
- Address
- 601 Carlson Pkwy Ste 890, Minnetonka, MN, United States, 55305
- Owner or operator
- Pleural Dynamics, Inc. (10088649)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- September 15, 2023
- Registered through
- 2026
- Brand names listed
- ACES Accessory Kit, ACES System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Ventricular, General & Plastic Surgery | GBS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Shunt, Peritoneal | KPM | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 18, 2023 | K231096 | Automatic Continuous Effusion Shunt (ACES) System ACES System | KPM | Substantially Equivalent | Pleural Dynamics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 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.