Data / Medical devices / United States / Curatia Medical Co.
Curatia Medical Co.: FDA-registered device maker in Sunnyvale, CA, United States, 6 510(k) clearances
Curatia Medical Co. is registered with the FDA (registration 3008361782) in Sunnyvale, CA, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 27, 2022. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3008361782
- Address
- 830 Stewart Drive, Sunnyvale, CA, United States, 94085
- Owner or operator
- Curatia Medical Co. (10031704)
- Roles
- Specification developer
- First device listed
- March 1, 2010
- Registered through
- 2027
- Brand names listed
- AutoSeal Hemostasis Valve, EXTesia Introducer Sheath Set, Navajo PTA Balloon Dilatation Catheter, URSA ANGIOGRAPHIC CATHETER, Ursa Angiographic Catheter, Vela RX PTA Balloon Dilatation Catheter, Xcess Guiding Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Specification developer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 27, 2022 | K220604 | EXTesia Introducer Sheath Set | DYB | Substantially Equivalent | Curatia Medical Co. | accessdata.fda.gov |
| December 14, 2018 | K180797 | Xcess Guiding Catheter | DQY | Substantially Equivalent | Curatia Medical Co. | accessdata.fda.gov |
| July 19, 2017 | K171290 | Vela RX PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | Curatia Medical | accessdata.fda.gov |
| January 30, 2015 | K141354 | NAVAJO PTA BALLOON DILATATION CATHETER | DQY | Substantially Equivalent | Curative Medical, Inc. | accessdata.fda.gov |
| March 4, 2013 | K123818 | URSA ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | Curative Medical Technology, Inc. | accessdata.fda.gov |
| January 29, 2010 | K090427 | URSA ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | Curative Medical Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Catheter
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Catheter, Percutaneous
Updated April 27, 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.