Atlas FDA

RAPID PROGRAMMER

FDA 510(k) clearance K113611 · decided 2012-04-20

Clearance details

K-number
K113611
Device name
RAPID PROGRAMMER
Applicant
St Jude Medical
Decision
Substantially Equivalent
Date received
2011-12-06
Decision date
2012-04-20
Days to decision
136 days
Clearance type
Traditional
Product code
GZB
Device class
2
Regulation number
882.5880
Medical specialty
Neurology
Advisory committee
Neurology
Location
Plano, TX, US
Third-party review
No
Expedited review
No

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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