Ab Astra
Country not established
- Devices
- 1
- FDA recalls
- 10 ongoing since 2021 (1 open in total)
At a glance
Market reach
- United States
- FDA recalls
What Ab Astra makes
Ab Astra manufactures the ASTRA-VAC, a Class I medical device designed for vacuum-assisted wound care, including drainage and irrigation of wounds.
The ASTRA-VAC is regulated under the FDA’s 510(k) pathway as a Class I device and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Astra-Vac Ref K782115
Regimes: 510(k) Registry: 510(k)
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 25 Apr 2019 Z-2100-2019 Class II Open since 2019 Failure to comply event due to incorrect labeling of a class 1 laser product.
Frequently asked questions
How many devices does Ab Astra have in the registry?
The registry currently lists 1 device for Ab Astra. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ab Astra's devices?
Among its 1 most recently registered device, Ab Astra has devices listed in FDA 510(k) (1 device).
What risk classes do Ab Astra's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ab Astra's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Ab Astra?
FDA recall records list 1 recall initiated by Ab Astra, the most recent initiated on 25 Apr 2019. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ab Astra in the registry?
The most recently registered devices listed for Ab Astra include ASTRA-VAC.