Data / Medical devices / Canada / Nipro Canada Corporation
Nipro Canada Corporation: FDA-registered device maker in LINDSAY Ontario, Canada, 3 510(k) clearances
Nipro Canada Corporation is registered with the FDA (registration 8020347) in LINDSAY Ontario, Canada. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 23, 2008. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8020347
- FEI number
- 3005612924
- Address
- 199 ST. David Street, LINDSAY Ontario, Canada, K9V 5K7
- Owner or operator
- NIPRO CANADA CORPORATION (8020347)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 22, 2001
- Registered through
- 2027
- Brand names listed
- ADULT HEART COOLING JACKET, CLAMPS, INFUSION STAND, O.R. Perfusion Cannulae, Punctur-Guard, TUBING ORGANIZER, TheraSafe Phlebotomy Bag w/needleless Y Adapter & 17GX1, TheraSafe Phlebotomy Bag w/needleless Y Adapter & 18GX1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Clamp, Line | FKK | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 23, 2008 | K080174 | PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C | LHI | Substantially Equivalent | Cardio Med Supplies, Inc. | accessdata.fda.gov |
| June 6, 1997 | K963748 | BIO-PLEXUS DROP-IT NEEDLE HOLDER | FMI | Substantially Equivalent | Bio-Plexus, Inc. | accessdata.fda.gov |
| November 28, 1983 | K833112 | TUBING FOR CARDIOPULMONARY BYPASS | DWF | Substantially Equivalent | Cardio Med Supplies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stand, Infusion
- All makers of Accessory Equipment, Cardiopulmonary Bypass
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- All makers of Set, I.V. Fluid Transfer
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Clamp, Line
Updated April 23, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.