CIRCULATOR BOOT
FDA 510(k) clearance K082134 · decided 2009-05-07
Clearance details
- K-number
- K082134
- Device name
- CIRCULATOR BOOT
- Applicant
- Circulator Boot Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-29
- Decision date
- 2009-05-07
- Days to decision
- 282 days
- Clearance type
- Traditional
- Product code
- DRN
- Device class
- 2
- Regulation number
- 870.5225
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.