Atlas FDA

Advisor VL Circular Mapping Catheter, Sensor Enabled

FDA 510(k) clearance K192037 · decided 2019-09-17

Clearance details

K-number
K192037
Device name
Advisor VL Circular Mapping Catheter, Sensor Enabled
Applicant
ABBOTT MEDICAL
Decision
Substantially Equivalent
Date received
2019-07-30
Decision date
2019-09-17
Days to decision
49 days
Clearance type
Traditional
Product code
DRF
Device class
2
Regulation number
870.1220
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Plymouth, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter (K210313)Shanghai Microport EP Medtech Co., Ltd.2022-12-30
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Recalls involving this device

No recalls on record reference this clearance.

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