Data / Medical devices / Costa Rica / Swav CR SRL
Swav CR SRL: FDA-registered device maker in Alajuela, Costa Rica, 1 510(k) clearance and 1 PMA approval
Swav CR SRL is registered with the FDA (registration 3027545377) in Alajuela, Costa Rica. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated March 22, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027545377
- Address
- Coyol Free Zone Building B50.B., El Coyol, Alajuela, Costa Rica, 20101
- Owner or operator
- Shockwave Medical, Inc. (10046972)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 16, 2021
- Registered through
- 2027
- Brand names listed
- Shockwave C2, Shockwave C2 Aero Coronary IVL Catheter, Shockwave C2 Aero Fly Coronary IVL Catheter, Shockwave C2 Catheter, Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter, Shockwave C2+, Shockwave C2+ Coronary IVL Catheter, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary IVL Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Percutaneous Catheter, Ultrasound | PPN | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Shockwave Intravascular Lithotripsy System | QMG | 3 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 22, 2024 | K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | PPN | Substantially Equivalent | Shockwave Medical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 12, 2021 | P200039 | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter | QMG | 24 | September 11, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Shockwave Intravascular Lithotripsy System
- All makers of Percutaneous Catheter, Ultrasound
Updated September 11, 2026. 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.