Atlas FDA

Assert-IQ™ Insertable Cardiac Monitor

FDA 510(k) clearance K230286 · decided 2023-05-17

Clearance details

K-number
K230286
Device name
Assert-IQ™ Insertable Cardiac Monitor
Applicant
ABBOTT MEDICAL
Decision
Substantially Equivalent
Date received
2023-02-02
Decision date
2023-05-17
Days to decision
104 days
Clearance type
Traditional
Product code
MXC
Device class
2
Regulation number
870.2800
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Sylmar, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Jot Dx Insertable Cardiac Monitor (K212206)Abbott (St. Jude Medical)2021-08-13
Confirm Rx Insertable Cardiac Monitor (K202876)Abbott (St. Jude Medical)2020-12-01
Confirm Rx Insertable Cardiac Monitor (K202888)Abbott (St. Jude Medical)2020-11-23
myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (K193310)Abbott (St. Jude Medical)2020-03-17
Confirm Rx Insertable Cardiac Monitor (K192593)Abbott2019-10-18
Confirm Rx Insertable Cardiac Monitor (K190295)Abbott (St. Jude Medical)2019-04-10
Confirm Rx Insertable Cardiac Monitor (K182981)Abbott2019-03-29
myMerlin(TM) Mobile Application Model APP1001 (K173232)St Jude Medical2017-11-02
Confirm Rx Insertable Cardiac Monitor (ICM) System (K163407)St. Jude Medical, Inc.2017-09-29
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (K133481)St. Jude Medical, Inc.2014-05-28
SJM CONFIRM (K122161)St Jude Medical2012-11-28
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (K122090)St. Jude Medical, Cardiac Rhythm Management Divisi2012-11-15

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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HeartMate 3™ Left Ventricular Assist System (P160054/S116)ABBOTT MEDICAL2025-12-17
Durata Leads; Optisure Leads (P950022/S151)ABBOTT MEDICAL2025-12-09