EXPORT ADVANCE ASPIRATION CATHETER
FDA 510(k) clearance K130536 · decided 2013-07-16
Clearance details
- K-number
- K130536
- Device name
- EXPORT ADVANCE ASPIRATION CATHETER
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-01
- Decision date
- 2013-07-16
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- QEZ
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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