Data / Medical devices / Catheter, Peritoneal, Long-Term Indwelling
Catheter, Peritoneal, Long-Term Indwelling (FJS): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make Catheter, Peritoneal, Long-Term Indwelling (product code FJS, Class 2, 21 CFR 876.5630). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 48 510(k) clearances under this code, the latest on January 14, 2022, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FJS
- Device class
- 2
- Regulation
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Mexico | 2 |
| Canada | 1 |
| Costa Rica | 1 |
Makers of Catheter, Peritoneal, Long-Term Indwelling
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 |
|---|---|---|---|---|---|---|---|---|
| Covidien LLC | Mansfield, MA, United States | Specification developer | 11 | January 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| Mozarc Medical Us LLC | Mansfield, MA, United States | Specification developer | 11 | January 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Manufacturer | 9 | July 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 7 | May 21, 2012 | 0 | 3 | 0 | api.fda.gov |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | September 5, 2012 | 0 | 0 | 0 | api.fda.gov |
| Medionics International, Inc. | MARKHAM Ontario, Canada | Manufacturer | 2 | April 19, 2013 | 0 | 0 | 0 | api.fda.gov |
| PFM Medical, Inc | Carlsbad, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | March 13, 2012 | 0 | 1 | 0 | api.fda.gov |
| Cardinal Health Costa Rica, S.A. | -- Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products | Harleysville, PA, United States | Contract manufacturer | 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 | |
| Merit Medical Systems, Inc. | Houston, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Point Medical Corp. | Crown Point, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Mansfield, Bridgemedica | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 14, 2022. 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.