Atlas FDA

VENTURE WIRE CONTROL CATHETER, MODEL WCC

FDA 510(k) clearance K061843 · decided 2006-08-01

Clearance details

K-number
K061843
Device name
VENTURE WIRE CONTROL CATHETER, MODEL WCC
Applicant
St Jude Medical
Decision
Substantially Equivalent
Date received
2006-06-30
Decision date
2006-08-01
Days to decision
32 days
Clearance type
Special
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Maple Grove, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Mo recall (Z-2224-2017)Vascular Solutions, Inc.2017-05-22

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