Atlas FDA

Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)

FDA 510(k) clearance K252417 · decided 2025-12-17

Clearance details

K-number
K252417
Device name
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
Applicant
ABBOTT MEDICAL
Decision
Substantially Equivalent
Date received
2025-08-01
Decision date
2025-12-17
Days to decision
138 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

+ Add to Predicate Builder ◉ Watch ABBOTT MEDICAL

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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 LP Delivery System; Amplatzer TorqVue LP Catheter (K261825)Abbott2026-07-02
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
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
Proclaim Dorsal Root Ganglion (DRG) System (P150004/S092)ABBOTT MEDICAL2025-12-23
Proclaim™ Spinal Cord Stimulation (SCS) System (P010032/S246)ABBOTT MEDICAL2025-12-23
Infinity™ Deep Brain Stimulation (DBS) System (P140009/S127)ABBOTT MEDICAL2025-12-23
Amplatzer™ Amulet™ Left Atrial Appendage Occluder (P200049/S014)ABBOTT MEDICAL2025-12-23
Volt™ PFA System (P250022)ABBOTT MEDICAL2025-12-19
HeartMate II™ Left Ventricular Assist System (P060040/S122)ABBOTT MEDICAL2025-12-17
HeartMate 3™ Left Ventricular Assist System (P160054/S116)ABBOTT MEDICAL2025-12-17
Durata Leads; Optisure Leads (P950022/S151)ABBOTT MEDICAL2025-12-09