Custom Coronary Manifold Kits
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K853749 FDA 510(k)
- FDA Product Code
- DTL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4290 FDA 510(k)
- Regulation Number
- 870.4290 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Custom Coronary Manifold Kits are classified as adaptors, stopcocks, manifolds, and fittings for cardiopulmonary bypass systems. These devices are designed to facilitate fluid management and connectivity in coronary artery bypass procedures, enabling precise control of blood flow and medication administration during cardiac surgery.
These kits are intended for use in sterile operating room environments and are supplied as single-use components. They are regulated under FDA 510(k) clearance (K853749) and fall under the classification of Class II medical devices (DTL). No MRI safety information or reusable specifications are provided in the data. The kits are customizable to meet specific procedural requirements and are manufactured by Procedure Products, Inc.
Frequently asked questions
What are the Custom Coronary Manifold Kits used for?
These kits are designed specifically for coronary artery bypass procedures to facilitate fluid management and connectivity in cardiopulmonary bypass systems. They enable precise control of blood flow and medication administration during cardiac surgery, ensuring optimal procedural outcomes.
Are the Custom Coronary Manifold Kits reusable or single-use?
The Custom Coronary Manifold Kits are intended for single-use only. This design ensures sterility and reduces the risk of contamination in sterile operating room environments, which is critical for cardiac surgery.
How are the Custom Coronary Manifold Kits supplied?
The kits are customizable to meet specific procedural requirements and are supplied as adaptors, stopcocks, manifolds, and fittings tailored for cardiopulmonary bypass systems. They are packaged for sterile use in the operating room.
What regulatory clearance do the Custom Coronary Manifold Kits hold?
The Custom Coronary Manifold Kits are cleared under the FDA 510(k) pathway with the clearance number K853749. They are classified as Class II medical devices under the product code DTL, indicating they are regulated for safety and performance in their intended use.
Can these kits be tailored to specific procedural needs?
Yes, the Custom Coronary Manifold Kits are designed to be customizable, allowing healthcare providers to configure them according to the specific requirements of their coronary artery bypass procedures. This flexibility ensures compatibility with various cardiopulmonary bypass systems.
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: CUSTOM CORONARY MANIFOLD KITS (K853749) — FDA 510(k) | Innolitics, Procedure Products, Class 2 Device Recall Custom Manifold Kit - accessdata.fda.gov, Procedure Products: Product Overview — Procedure Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K853749 | Class II | Active |
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Manufacturer
- Manufacturer
- Procedure Products, Inc.
Sources (1)
- FDA 510(k) K853749 24 fields · synced Oct 1, 2026