Data / Medical devices / Costa Rica / Terumo Cardiovascular Costa Rica LLC
Terumo Cardiovascular Costa Rica LLC: FDA-registered device maker in Zona Franca La Lima Cartago, Costa Rica, 10 510(k) clearances
Terumo Cardiovascular Costa Rica LLC is registered with the FDA (registration 3017987980) in Zona Franca La Lima Cartago, Costa Rica. It lists 8 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 5, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017987980
- Address
- Calle 58, Zona Franca La Lima Cartago, Costa Rica, 30106
- Owner or operator
- Terumo Cardiovascular Systems Corp. (10039199)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 16, 2021
- Registered through
- 2026
- Brand names listed
- Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass, Breathing Circuit, Breathing circuit filter, CPB Check Valve, Cardiovascular Procedure Kit, Catheter/Tubing, HEAT-EXCHANGER, Pump Tubing
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Manufacturer | accessdata.fda.gov |
| Cardiovascular Procedure Kit | OEZ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Manufacturer | accessdata.fda.gov |
| Cpb Check Valve, Retrograde Flow, In-Line | MJJ | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer | accessdata.fda.gov |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Blood-Pressure, Extravascular | DRS | 2 | Manufacturer | accessdata.fda.gov |
| Tubing, Pump, Cardiopulmonary Bypass | DWE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 5, 2015 | K150536 | Terumo Circuit Tubing | DWF | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| May 1, 2015 | K150542 | Terumo Pump Tubing | DWE | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| January 29, 2015 | K142500 | One Way Soft Valve | MJJ | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| May 19, 2010 | K093992 | TERUMO LAUER LOCK ADAPTER | DTL | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| December 10, 2009 | K092644 | TERUMO PRESSURE ISOLATOR | DRS | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| August 11, 2004 | K041697 | TERUMO CIRCUIT CONNECTORS | DTL | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| June 10, 2002 | K021020 | TERUMO GAS FILTER | CAH | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| January 22, 2002 | K013578 | PUMP TUBING | DWE | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| March 23, 2001 | K000977 | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS | DTR | Substantially Equivalent | Olson Medical Sales, Inc. | accessdata.fda.gov |
| March 1, 2000 | K993189 | CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING | DWE | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Heat-Exchanger, Cardiopulmonary Bypass
- All makers of Cardiovascular Procedure Kit
- All makers of Cpb Check Valve, Retrograde Flow, In-Line
- All makers of Transducer, Blood-Pressure, Extravascular
Updated May 5, 2015. 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.