Ostial Corporation
United StatesFDA applicant, unverified
- Devices
- 12
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Ostial Corporation makes
Ostial Corporation manufactures percutaneous transluminal angioplasty (PTA) balloon dilatation catheters and ostial stent systems for vascular and biliary applications. The portfolio includes mini ostial systems in varying diameters and lengths, designed for treating stenoses at vessel origins, alongside over-the-wire (OTW) ostial systems for larger ostial lesions. Additional products are PTA balloons in multiple sizes for dilating narrowed arteries and bile ducts, including both standard and Flash-C variants for enhanced performance.
These devices are classified as Class II under the US FDA regulatory framework and are recorded in the FDA’s 510(k) premarket notification database. The company is based in the United States, and its products are subject to FDA oversight for safety and performance before commercialisation.
Catalogue
Search and filter all 12 devicesFDA recalls
FDA recall records list 1 recall initiated by Ostial Corporation, initiated on 2021-07-14. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 14 Jul 2021 Z-2309-2021 Class II Terminated Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.
Frequently asked questions
How many devices does Ostial Corporation have in the registry?
The registry currently lists 12 devices for Ostial Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ostial Corporation's devices?
Among its 12 most recently registered devices, Ostial Corporation has devices listed in FDA 510(k) (12 devices).
What risk classes do Ostial Corporation's devices fall under?
Among its 12 most recently registered devices, the classes recorded for Ostial Corporation's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ostial Corporation?
FDA recall records list 1 recall initiated by Ostial Corporation, the most recent initiated on 14 Jul 2021. 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 Ostial Corporation in the registry?
The most recently registered devices listed for Ostial Corporation include FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM, ARCHSTENT BILIARY SYSTEM and FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM.