CHARTIS CATHETER
FDA 510(k) clearance K083883 · decided 2009-06-25
Clearance details
- K-number
- K083883
- Device name
- CHARTIS CATHETER
- Applicant
- Pulmonx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-29
- Decision date
- 2009-06-25
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- CBI
- Device class
- 2
- Regulation number
- 868.5740
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Woodinville, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.