KARDIUM Inc.
Burnaby British Columbia, CA
KARDIUM Inc. appears in FDA device records in Burnaby British Columbia, CA. FDA records list 2 510(k) clearances between and , 6 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for KARDIUM Inc. in 2025.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2025 | 2 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007603855 | 3007603855 | KARDIUM Inc. | 8518 Glenlyon Parkway, Unit 155, Burnaby British Columbia V5J0B6 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- QWACardiovascular Delivery Catheter System Positioning And Stabilization Device
- OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- DRACatheter, Steerable
- DQKComputer, Diagnostic, Programmable
- DYBIntroducer, Catheter
- QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- HXSTwister, Wire
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0054-2013 | TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or large shipping carton containing six (6) shelf boxes (for a total of 6 x 10 = 60 devices). This product is used to close the sternal wires during cardiac surgery, and it is not an implantable device. The TORQ Sternal Closure device is used during sternal closure to tension and twist standard stainless steel surgical sutures of USP size 6 or 7 (metric size 8.0 or 9.0). The TORQ device is designed for use as a standard surgical suture wire twister for sternal closure. (Surgical sutures are not provided with the device.) The TORQ device is disposable, single-use, non-implantable and supplied sterile. | The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use. | Class II | Terminated | |
| Z-1973-2010 | TORQ Sternal Closure Device, SINGLE-USE Intended use: The device is a sterile, single-use only surgical instrument used to tension and twist USP size 5, 6, and 7 (metric size 7.0, 8.0, and 9.0) stainless steel surgical sutures for sternal closure. The device should not be used on patients with poor sternal bone quality. | A component of the device is installed incorrectly which can result in the component falling out of the device and into the patient during use. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain