ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
FDA 510(k) clearance K170958 · decided 2017-08-29
Clearance details
- K-number
- K170958
- Device name
- ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
- Applicant
- Tricol Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-03-31
- Decision date
- 2017-08-29
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.