Data / Medical devices / United States / Centese, Inc.
Centese, Inc.: FDA-registered device maker in Omaha, NE, United States, 1 510(k) clearance
Centese, Inc. is registered with the FDA (registration 3017435705) in Omaha, NE, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 29, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017435705
- Address
- 4156 S 52nd St, Omaha, NE, United States, 68117
- Owner or operator
- Centese, Inc. (10077932)
- Roles
- Manufacturer
- First device listed
- October 6, 2020
- Registered through
- 2026
- Brand names listed
- Thoraguard
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | 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 |
|---|---|---|---|---|---|---|
| November 29, 2018 | K181667 | Thoraguard System | BTA | Substantially Equivalent | Centese, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 31, 2021 | 88616 | Class II | Terminated | Thoraguard Chest Tube Kit, 20 Fr | An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak. | accessdata.fda.gov |
Compare with other makers
Updated November 29, 2018. 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.