STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE
FDA 510(k) clearance K002273 · decided 2001-01-29
Clearance details
- K-number
- K002273
- Device name
- STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE
- Applicant
- Stoeckert Instrumente
- Decision
- Substantially Equivalent
- Date received
- 2000-07-26
- Decision date
- 2001-01-29
- Days to decision
- 187 days
- Clearance type
- Abbreviated
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Arvada, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.