Jostra Venous Softbag Reservoirs With and Without Safeline Coating
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070605 FDA 510(k)
- FDA Product Code
- DTN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4400 FDA 510(k)
- Regulation Number
- 870.4400 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Jostra Venous Softbag Reservoirs are cardiopulmonary bypass blood reservoirs used in extracorporeal circuits. They are designed for use during cardiopulmonary bypass procedures in open-heart surgery.
This device has received FDA 510(k) clearance. It is manufactured by Maquet Cardiopulmonary AG.
Frequently asked questions
What is the primary clinical use of the Jostra Venous Softbag Reservoir?
This device is a cardiopulmonary bypass blood reservoir designed for use in extracorporeal circuits during open-heart surgery procedures.
Are there different versions of the Jostra Venous Softbag Reservoir available?
Yes, the product line includes reservoirs both with and without the Safeline coating to accommodate different clinical requirements for extracorporeal circuits.
What is the regulatory status of this device?
The Jostra Venous Softbag Reservoirs have received FDA 510(k) clearance, which indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Jostra Venous Softbag Reservoirs With and Without Safeline Coating ..., Jostra Venous Softbag Reservoirs With and Without Safeline Coating, PDF Koyo&og - Food and Drug Administration, PDF K070605 Jostra Venous Softbag Reservoirs With and Without Safeline Coating, VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING by MAQUET ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070605 | Class II | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary AG
- FDA Applicant
- Maquet Cardiopulmonary, AG
Sources (1)
- FDA 510(k) K070605 24 fields · synced Oct 6, 2026