Atlas FDA

REFLEXION HD HIGH-DENSITY MAPPING CATHETER

FDA 510(k) clearance K080179 · decided 2009-01-07

Clearance details

K-number
K080179
Device name
REFLEXION HD HIGH-DENSITY MAPPING CATHETER
Applicant
St Jude Medical
Decision
Substantially Equivalent
Date received
2008-01-24
Decision date
2009-01-07
Days to decision
349 days
Clearance type
Traditional
Product code
DRF
Device class
2
Regulation number
870.1220
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minnetonka, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
02.122.590, 90mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1291-2011)Synthes USA (HQ), Inc.2011-02-16

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