CSTAT, MODELS 09-0014-01 AND 09-0014-02
FDA 510(k) clearance K032125 · decided 2004-02-09
Clearance details
- K-number
- K032125
- Device name
- CSTAT, MODELS 09-0014-01 AND 09-0014-02
- Applicant
- Vascular Control Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-10
- Decision date
- 2004-02-09
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Juan Capistrano, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.