Data / Medical devices / Central Venous Catheter With Manual Insertion System
Central Venous Catheter With Manual Insertion System (SEF): 3 FDA-registered makers in 3 countries
3 establishments in 3 countries are registered with the FDA to make Central Venous Catheter With Manual Insertion System (product code SEF, Class 2, 21 CFR 880.5200). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on April 9, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SEF
- Device class
- 2
- Regulation
- 880.5200
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 1 |
| India | 1 |
| Mexico | 1 |
Makers of Central Venous Catheter With Manual Insertion System
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 |
|---|---|---|---|---|---|---|---|---|
| Bard Access Systems, Inc. | Salt Lake City, UT, United States | Manufacturer, Specification developer | 1 | April 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| AUSA Medical Device Pvt Ltd | Bangalore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Reynosa S.A. De C.V. | REYNOSA Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 9, 2025. 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.