Atlas FDA

ULTIMUM/ENGAGE/ENGAGE TR

FDA 510(k) clearance K091137 · decided 2009-04-22

Clearance details

K-number
K091137
Device name
ULTIMUM/ENGAGE/ENGAGE TR
Applicant
St Jude Medical
Decision
Substantially Equivalent
Date received
2009-04-20
Decision date
2009-04-22
Days to decision
2 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minnetonka, MN, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidew recall (Z-2178-2010)St. Jude Medical Cardiovascular Division2010-08-12
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guide recall (Z-2179-2010)St. Jude Medical Cardiovascular Division2010-08-12
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guide recall (Z-2180-2010)St. Jude Medical Cardiovascular Division2010-08-12
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .035" Max Guide recall (Z-2181-2010)St. Jude Medical Cardiovascular Division2010-08-12
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .038" Max Guide recall (Z-2182-2010)St. Jude Medical Cardiovascular Division2010-08-12

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