Data / Medical devices / United States / Alembic LLC

Alembic LLC: FDA-registered device maker in Mountain View, CA, United States, 10 510(k) clearances

Name: Alembic LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Alembic LLC is registered with the FDA (registration 3014211783) in Mountain View, CA, United States. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 1, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014211783
Address: 627 National Ave., Mountain View, CA, United States, 94043
Owner or operator: Alembic LLC (10056521)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: December 21, 2017
Registered through: 2026
Brand names listed: APRO 45 Intermediate Catheter, APRO 45 Swift Catheter, APRO 55 Catheter, APRO 55 Catheter and Alembic Aspiration Tubing, APRO 55 Intermediate Catheter, APRO 55 Swift Catheter, APRO 70 Catheter, APRO 70 Swift Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Continuous Flush	KRA	2	Contract manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 1, 2025	K251014	APRO 45 Catheter	DQY	Substantially Equivalent	Alembic, LLC	accessdata.fda.gov
April 30, 2025	K251015	APRO 45 Catheter and Alembic Aspiration Tubing	NRY	Substantially Equivalent	Alembic, LLC	accessdata.fda.gov
April 29, 2025	K250962	APRO 55 Intermediate Catheter	DQY	Substantially Equivalent	Alembic, LLC	accessdata.fda.gov
April 28, 2025	K250958	APRO 55 Swift Catheter and Alembic Aspiration Tubing	NRY	Substantially Equivalent	Alembic, LLC	accessdata.fda.gov
February 24, 2025	K243287	APRO 70 Swift Catheter and Alembic Aspiration Tubing	NRY	Substantially Equivalent	Alembic, LLC	accessdata.fda.gov
January 14, 2025	K243297	APRO 70 Swift Catheter	QJP	Substantially Equivalent	Alembic, LLC	accessdata.fda.gov
March 15, 2024	K234115	APRO 55 Catheter	DQY	Substantially Equivalent	Alembic, LLC	accessdata.fda.gov
February 29, 2024	K232971	APRO 55 Catheter and Alembic Aspiration Tubing	NRY	Substantially Equivalent	Alembic, LLC	accessdata.fda.gov
April 10, 2023	K230695	APRO 70 Catheter and Alembic Aspiration Tubing	NRY	Substantially Equivalent	Alembic, LLC	accessdata.fda.gov
February 17, 2023	K223545	APRO 70 Catheter and Alembic Aspiration Tubing	NRY	Substantially Equivalent	Alembic, LLC	accessdata.fda.gov

Compare with other makers

Updated May 1, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.