Support Catheter
FDA 510(k) clearance K200317 · decided 2020-05-14
Clearance details
- K-number
- K200317
- Device name
- Support Catheter
- Applicant
- Qxmedical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-02-07
- Decision date
- 2020-05-14
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Saint Paul, MN, 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.