Atlas FDA

Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter

FDA 510(k) clearance K261825 · decided 2026-07-02

Clearance details

K-number
K261825
Device name
Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
Applicant
Abbott
Decision
Substantially Equivalent
Date received
2026-06-02
Decision date
2026-07-02
Days to decision
30 days
Clearance type
Special
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Saint Paul, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
CPS Locator 3D Plus Delivery Catheter (K261766)CenterPoint Systems, LLC2026-07-29
SSPC NXT Delivery Catheter (K262240)CenterPoint Systems, LLC2026-07-29
Amplatzer TorqVue Exchange System (K261631)Abbott Medical2026-06-17
Perfect-O Ostial Positioning Catheter (K260289)Balosmark, Inc.2026-06-05
Amplatzer TorqVue Delivery System (K260993)Abbott2026-04-24
Teleport Glide Microcatheter (K253361)OrbusNeich Medical (Shenzhen) Co., Ltd.2026-04-10
Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499)ABBOTT MEDICAL2026-03-13
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409)Medtronic, Inc.2025-12-19
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (K252417)ABBOTT MEDICAL2025-12-17
Telescope Guide Extension Catheter (K252390)Medtronic, Ireland2025-10-29
CPS Locator 3D Delivery Catheter (K250147)Centerpoint Systems2025-08-22
CoraForce Microcatheter, CoraFlex Microcatheter (K251277)Reflow Medical, Inc.2025-08-22

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CentriMag™ Circulatory Support System (P170038/S031)Abbott2026-05-05
CentriMag™ Circulatory Support System (P170038/S030)Abbott2026-05-04
CentriMag™ Circulatory Support System (P170038/S029)Abbott2026-04-17
CentriMag Circulatory Support System (P170038/S028)Abbott2026-02-18
CentriMag Circulatory Support System (P170038/S027)Abbott2026-02-03
CentriMag™ Circulatory Support System (P170038/S025)Abbott2025-12-01
CentriMag Circulatory Support System (P170038/S023)Abbott2025-09-29
CentriMag™ Circulatory Support System (P170038/S026)Abbott2025-08-21