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FDA 510(k)

APRO 45 Catheter and Alembic Aspiration Tubing

K-Number: K251015 · 2025-04-30

ApplicantAlembic, LLC
Decision Date2025-04-30
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APRO 45 Catheter and Alembic Aspiration Tubing is a medical device manufactured by Alembic, LLC. It received FDA 510(k) clearance on 2025-04-30 under approval number K251015. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APRO 45 Catheter and Alembic Aspiration Tubing?

APRO 45 Catheter and Alembic Aspiration Tubing is a medical device that received FDA 510(k) clearance on 2025-04-30. It is manufactured by Alembic, LLC. The 510(k) number is K251015.

When was APRO 45 Catheter and Alembic Aspiration Tubing approved by the FDA?

APRO 45 Catheter and Alembic Aspiration Tubing received FDA 510(k) clearance on 2025-04-30, under approval number K251015.

What company makes APRO 45 Catheter and Alembic Aspiration Tubing?

APRO 45 Catheter and Alembic Aspiration Tubing is manufactured by Alembic, LLC.

What is the FDA product code for APRO 45 Catheter and Alembic Aspiration Tubing?

The FDA product code for APRO 45 Catheter and Alembic Aspiration Tubing is NRY.

Related Clinical Trials

NCT07216170 REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke NOT_YET_RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07571954 Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy NOT_YET_RECRUITING NCT06615713 CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones COMPLETED

Other Devices by Alembic, LLC

K230695APRO 70 Catheter and Alembic Aspiration Tubing K223545APRO 70 Catheter and Alembic Aspiration Tubing K234115APRO 55 Catheter K232971APRO 55 Catheter and Alembic Aspiration Tubing K251014APRO 45 Catheter K250962APRO 55 Intermediate Catheter

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Related Devices (Code: NRY)

K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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