Atlas FDA

MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)

FDA 510(k) clearance K243224 · decided 2024-12-31

Clearance details

K-number
K243224
Device name
MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)
Applicant
ABBOTT MEDICAL
Decision
Substantially Equivalent
Date received
2024-10-07
Decision date
2024-12-31
Days to decision
85 days
Clearance type
Traditional
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
St. Paul, MN, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S259)ABBOTT MEDICAL2026-07-26
Dorsal Root Ganglion (DRG) IPG (P150004/S099)ABBOTT MEDICAL2026-07-26
Deep Brain Stimulation (DBS) IPG (P140009/S138)ABBOTT MEDICAL2026-07-26
Current™ PFA Generator – TactiFlex Duo (P250022/S005)ABBOTT MEDICAL2026-07-23