Atlas FDA

Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter

FDA 510(k) clearance K181458 · decided 2018-10-27

Clearance details

K-number
K181458
Device name
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
Applicant
Innovative Health, LLC
Decision
Substantially Equivalent
Date received
2018-06-04
Decision date
2018-10-27
Days to decision
145 days
Clearance type
Traditional
Product code
NLH
Device class
2
Regulation number
870.1220
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Scottsdale, AZ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.