Data / Medical devices / Graft, Vascular, Stainless Steel Tunneler
Graft, Vascular, Stainless Steel Tunneler (MZY): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Graft, Vascular, Stainless Steel Tunneler (product code MZY, Class 2, 21 CFR 870.3450). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- MZY
- Device class
- 2
- Regulation
- 870.3450
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Mexico | 2 |
| Germany | 2 |
| India | 1 |
| Pakistan | 1 |
Makers of Graft, Vascular, Stainless Steel Tunneler
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Arrow Internacional de Chihuahua S.A. de C.V. | Chihuahua, Mexico | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gesco Healthcare Private Limited | CHENNAI, Tamil Nadu, India | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HGR Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products S. De RL. De CV. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudolf Storz GMBH | EMMINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.