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Sign in to claim this brandCorcym Canada Corp
US
Last updated May 23, 2026
What Corcym Canada Corp makes
Corcym Canada Corp manufactures bioprosthetic aortic heart valves designed for open-surgery implantation, including models combined with synthetic polymer aorta grafts. Their portfolio also includes specialized tools such as heart valve prosthesis sizing handles, single-use testing devices for valve leaflets, and reusable instrument trays for surgical procedures. Examples include the PERCEVAL and PERCEVAL PLUS valves, as well as accessory components like the Mitroflow Valsalva Conduit and Mitroflow Aortic Handle.
The company’s devices are regulated under both Class I and Class III classifications in the US, with several products listed under FDA’s Premarket Approval (PMA) and Unique Device Identification (UDI) programs. These products are intended for use in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Corcym Canada Corp manufacture?
Corcym Canada Corp specializes in bioprosthetic aortic heart valves designed for open-surgery implantation. Their portfolio includes standalone aortic valves and combined models featuring synthetic polymer aorta grafts. Additionally, they produce surgical tools such as heart valve sizing handles, single-use leaflet testers, and reusable instrument trays to support valve implantation procedures. Examples include the PERCEVAL and PERCEVAL PLUS valves, as well as accessories like the Mitroflow Valsalva Conduit and Mitroflow Aortic Handle.
Where is Corcym Canada Corp based, and where are their devices intended for use?
Corcym Canada Corp is based in the United States. Their devices are specifically intended for use in the US market, where regulatory oversight applies. The company’s manufacturing and regulatory focus align with this geographic scope.
Which regulatory registries or programs list Corcym Canada Corp’s devices?
Corcym Canada Corp’s devices are listed under the FDA’s Premarket Approval (PMA) program for certain high-risk products, as well as the Unique Device Identification (UDI) program. These registries ensure traceability and compliance for devices classified under Class I and Class III in the US, with Class III typically requiring stricter pre-market approval due to higher risk.
How are Corcym Canada Corp’s devices classified under US regulations?
Corcym Canada Corp’s devices are classified under both Class I and Class III in the US. Class III classifications apply to higher-risk products like bioprosthetic heart valves, which require rigorous pre-market approval (e.g., PMA) to ensure safety and effectiveness. Class I devices, which pose minimal risk, may have less stringent regulatory requirements, though the company’s portfolio primarily focuses on Class III products due to their complexity and critical use in surgery.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 204322622
Catalogue (40)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Perceval Plus | PVF-L | FDA UDI | Class III | Active |
| Perceval | PVS23 | FDA UDI | Class III | Active |
| Freedom Solo | ART25SG | FDA UDI | Class III | Unknown |
| Mitroflow | DLA21 | FDA UDI | Class III | Unknown |
| Crown Prt | CNA23 | FDA UDI | Class III | Unknown |
| Mitroflow Valsalva Conduit | MVC28 | FDA UDI | Class III | Unknown |
| Mitroflow | DLA27 | FDA UDI | Class III | Unknown |
| Mitroflow | DLA23 | FDA UDI | Class III | Unknown |
| Mitroflow | LXA25 | FDA UDI | Class III | Unknown |
| Mitroflow | LXA27 | FDA UDI | Class III | Unknown |
| Solo Smart | ART23SMT | FDA UDI | Class III | Unknown |
| Perceval | PVS25 | FDA UDI | Class III | Active |
| Mitroflow Accessory Tray | AT-11 | FDA UDI | Class I | Active |
| Solo Smart | ART25SMT | FDA UDI | Class III | Unknown |
| Mitroflow | DLA19 | FDA UDI | Class III | Unknown |
| Freedom Solo | ART21SG | FDA UDI | Class III | Unknown |
| Crown Prt | CNA19 | FDA UDI | Class III | Unknown |
| Crown Prt | CNA25 | FDA UDI | Class III | Unknown |
| Mitroflow | DLA25 | FDA UDI | Class III | Unknown |
| Perceval | PVS27 | FDA UDI | Class III | Active |
| Mitroflow Valsalva Conduit | MVC | FDA UDI | Class III | Active |
| Mitroflow Aortic Handle | AH-11 | FDA UDI | Class I | Active |
| Perceval | PVS21 | FDA UDI | Class III | Active |
| Crown Prt | CNA21 | FDA UDI | Class III | Unknown |
| Leaflet Tester | VT-100 | FDA UDI | Class I | Active |
| Perceval Plus | PVF-M | FDA UDI | Class III | Active |
| Mitroflow | LXA21 | FDA UDI | Class III | Unknown |
| Freedom Solo | ART27SG | FDA UDI | Class III | Unknown |
| Mitroflow Valsalva Conduit | MVC26 | FDA UDI | Class III | Unknown |
| Crown Prt | CNA27 | FDA UDI | Class III | Unknown |
| Mitroflow | LXA23 | FDA UDI | Class III | Unknown |
| Mitroflow Valsalva Conduit | MVC | FDA UDI | Class III | Active |
| Solo Smart | ART21SMT | FDA UDI | Class III | Unknown |
| Freedom Solo | ART23SG | FDA UDI | Class III | Unknown |
| Perceval Plus | PVF-XL | FDA UDI | Class III | Active |
| Mitroflow | LXA19 | FDA UDI | Class III | Unknown |
| Solo Smart | ART27SMT | FDA UDI | Class III | Unknown |
| Perceval Plus | PVF-S | FDA UDI | Class III | Active |
| Solo Smart Heart Valve | P130011 | FDA PMA | Class III | Active |
| Mitroflow Aortic Pericardial Heart Valve | P060038 | FDA PMA | Class III | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Corcym Canada Corp. Burnaby British Columbia · CA FEI 3004478276