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FDA 510(k)

APRO 55 Swift Catheter and Alembic Aspiration Tubing

K-Number: K250958 · 2025-04-28

ApplicantAlembic, LLC
Decision Date2025-04-28
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APRO 55 Swift Catheter and Alembic Aspiration Tubing is a medical device manufactured by Alembic, LLC. It received FDA 510(k) clearance on 2025-04-28 under approval number K250958. 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 55 Swift Catheter and Alembic Aspiration Tubing?

APRO 55 Swift Catheter and Alembic Aspiration Tubing is a medical device that received FDA 510(k) clearance on 2025-04-28. It is manufactured by Alembic, LLC. The 510(k) number is K250958.

When was APRO 55 Swift Catheter and Alembic Aspiration Tubing approved by the FDA?

APRO 55 Swift Catheter and Alembic Aspiration Tubing received FDA 510(k) clearance on 2025-04-28, under approval number K250958.

What company makes APRO 55 Swift Catheter and Alembic Aspiration Tubing?

APRO 55 Swift Catheter and Alembic Aspiration Tubing is manufactured by Alembic, LLC.

What is the FDA product code for APRO 55 Swift Catheter and Alembic Aspiration Tubing?

The FDA product code for APRO 55 Swift Catheter and Alembic Aspiration Tubing is NRY.

Related Clinical Trials

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Other Devices by Alembic, LLC

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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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