Atlas FDA

EPICOR ABLATION SYSTEM

FDA 510(k) clearance K080292 · decided 2008-07-25

Clearance details

K-number
K080292
Device name
EPICOR ABLATION SYSTEM
Applicant
St Jude Medical
Decision
Substantially Equivalent
Date received
2008-02-04
Decision date
2008-07-25
Days to decision
172 days
Clearance type
Special
Product code
OCL
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
St. Paul, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized w recall (Z-1780-2010)St. Jude Medical Atrial Fibrillation Division Inc2010-06-07
Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor C recall (Z-0946-2009)St. Jude Medical Inc2009-01-30

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