Data / Medical devices / Catheter, Ventricular
Catheter, Ventricular (HCA): 10 FDA-registered makers in 6 countries
10 establishments in 6 countries are registered with the FDA to make Catheter, Ventricular (product code HCA, Class 2, 21 CFR 882.4100). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on March 27, 2017, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HCA
- Device class
- 2
- Regulation
- 882.4100
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 3 |
| Switzerland | 1 |
| Dominican Republic | 1 |
| Mexico | 1 |
| Malaysia | 1 |
Makers of Catheter, Ventricular
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 |
|---|---|---|---|---|---|---|---|---|
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Manufacturer, Specification developer | 3 | May 14, 2003 | 0 | 0 | 0 | api.fda.gov |
| Integra LifeSciences Switzerland Sarl | Le Locle Neuchatel, Switzerland | Manufacturer | 2 | May 14, 2003 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 1 | April 5, 2002 | 0 | 0 | 0 | api.fda.gov |
| Brainlab Se | Munich Bavaria, Germany | Manufacturer | 1 | August 16, 2013 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Neurosurgery | Fort Worth, TX, United States | Specification developer | 1 | December 16, 1998 | 0 | 0 | 0 | api.fda.gov |
| christoph miethke gmbh & co.kg | potsdam Brandenburg, Germany | Manufacturer | 1 | April 5, 2002 | 0 | 0 | 0 | api.fda.gov |
| CEA Medical Manufacturing, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Manufacturing Sdn. Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 27, 2017. 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.