Atlas FDA

SJM ATTUNE ANNULOPLASTY RING

FDA 510(k) clearance K092876 · decided 2009-10-16

Clearance details

K-number
K092876
Device name
SJM ATTUNE ANNULOPLASTY RING
Applicant
St Jude Medical
Decision
Substantially Equivalent
Date received
2009-09-18
Decision date
2009-10-16
Days to decision
28 days
Clearance type
Special
Product code
KRH
Device class
2
Regulation number
870.3800
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
St.Paul, MN, 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