Data / Medical devices / Catheter, Infusion
Catheter, Infusion (JCY): 24 FDA-registered makers in 12 countries
24 establishments in 12 countries are registered with the FDA to make Catheter, Infusion (product code JCY, Class 1, 21 CFR 878.4200). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on October 24, 1986, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JCY
- Device class
- 1
- Regulation
- 878.4200
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 4 |
| Mexico | 3 |
| Pakistan | 2 |
| India | 2 |
| Dominican Republic | 1 |
| Chile | 1 |
| Italy | 1 |
| Malaysia | 1 |
| Vietnam | 1 |
| Israel | 1 |
| Germany | 1 |
Makers of Catheter, Infusion
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 |
|---|---|---|---|---|---|---|---|---|
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 1 | November 2, 1976 | 0 | 0 | 0 | api.fda.gov |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 14, 1984 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Dominican Republic Inc. | SANTO DOMINGO Distrito Nacional, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blunding S.A. | MACUL SANTIAGO Region Metropolitana, Chile | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Border Opportunity Saver Systems, Inc. | Del Rio, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Delta Med SPA | Delebio Sondrio, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospitech Manufacturing Services Sdn Bhd | Shah Alam Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hynaut Health Technology Co., LTD. | Qingdao Shandong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquiladora De Coahuila S De RL De CV | CUIDAD ACUNA Coahuila, Mexico | Contract manufacturer, Manufacturer, Repackager or relabeler | 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 | |
| MB Regentox Vietnam Trading Service Company Limited | Ho Chi Minh City, Vietnam | Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Risenmed Technology Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peak Medical Ltd. | Netanya Central, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surjex | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ustomed Instrumente GMBH & Co. KG | Tuttlingen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xinhua Surgical Instrument Co. Ltd. | ZIBO Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Anji Huabu Industrial Co., Ltd. | HUZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 24, 1986. 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.