APRO 45 Catheter

FDA 510(k) K251014 · Alembic, LLC

Substantially Equivalent

510(k) numberK251014

Submission

Device name
APRO 45 Catheter
Applicant
Alembic, LLC
Mountain View, CA, US
Received
April 2, 2025
Decision date
May 1, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQY – Catheter, Percutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

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More from Abbott Medical

510(k)DeviceDecision
K262392APRO 35 Swift CatheterDQY · Special 08/12/2026SE
K262391APRO 35 Swift Catheter and Alembic Aspiration TubingNRY · Special 08/12/2026SE
K251015APRO 45 Catheter and Alembic Aspiration TubingNRY · Special 04/30/2025SE
K250962APRO 55 Intermediate CatheterDQY · Special 04/29/2025SE
K250958APRO 55 Swift Catheter and Alembic Aspiration TubingNRY · Special 04/28/2025SE
K243287APRO 70 Swift Catheter and Alembic Aspiration TubingNRY · Traditional 02/24/2025SE
K243297APRO 70 Swift CatheterQJP · Special 01/14/2025SE
K234115APRO 55 CatheterDQY · Traditional 03/15/2024SE
K232971APRO 55 Catheter and Alembic Aspiration TubingNRY · Traditional 02/29/2024SE
K230695APRO 70 Catheter and Alembic Aspiration TubingNRY · Special 04/10/2023SE

Questions and answers

When was APRO 45 Catheter cleared by the FDA?

APRO 45 Catheter (K251014) received a 510(k) decision of Substantially Equivalent on May 1, 2025, 29 days after the submission was received.

What is the product code of K251014?

The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.