Atlas FDA

SJM CONFIRM

FDA 510(k) clearance K122161 · decided 2012-11-28

Clearance details

K-number
K122161
Device name
SJM CONFIRM
Applicant
St Jude Medical
Decision
Substantially Equivalent
Date received
2012-07-20
Decision date
2012-11-28
Days to decision
131 days
Clearance type
Traditional
Product code
MXC
Device class
2
Regulation number
870.2800
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Sunnyvale, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch St Jude Medical

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
Assert-IQ™ Insertable Cardiac Monitor (K230286)ABBOTT MEDICAL2023-05-17
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 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
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (P130026/S096)St Jude Medical2025-12-23
TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S094)St Jude Medical2025-06-20
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (P130026/S095)St Jude Medical2025-05-06
Safire™ Bi-Directional Ablation Catheter; Safire™ Catheter Extension Cable (P960016/S092)St Jude Medical2025-04-10
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (P130026/S093)St Jude Medical2025-04-10
TactiCath Ablation Catheter, Sensor Enabled (TactiCath SE) (P130026/S092)St Jude Medical2024-11-27
TactiCath Ablation Catheter, Sensor Enabled (P130026/S091)St Jude Medical2024-11-22
TactiCath Contact Force Ablation Catheter (P130026/S090)St Jude Medical2024-10-09