Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014211783

FEI Number

3014211783

Entity Name

ALEMBIC LLC

City/State/Country

Mountain View, CA, US

Establishment Address

627 National Ave., Mountain View, CA 94043, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Alembic LLC (Owner Number: 10056521)

Owner / Operator Contact Address

627 National Ave., Mountain View, CA 94043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251015

PMA Number

N/A

All Registered Proprietary Names

APRO 70 Swift Catheter APRO 55 Swift Catheter APRO 70 Catheter Alembic Aspiration Tubing APRO 45 Intermediate Catheter APRO 55 Catheter and Alembic Aspiration Tubing APRO 55 Intermediate Catheter APRO 55 Catheter APRO 70 Swift Catheter Alembic Aspiration Tubing APRO 70 Catheter APRO 55 Intermediate Catheter APRO 45 Swift Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-02-26
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-06-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2018-07-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-07-17
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2023-04-21
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2026-03-23
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2026-03-23
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2024-04-03
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-04-03
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-04-03
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-02-26
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2025-02-26
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2023-04-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-06-11
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2025-06-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-12-21
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2017-12-21
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2026-03-23

Official Correspondent

Lisa Yen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alembic LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033736	Concentric Medical, Inc.	MERCI RETRIEVER, MODELS 90065, 90066	2004-08-11
K792141	Pharmaseal Div., Baxter Healthcare Corp.	CONTINUOUS FLUSH DEVICE	1979-12-05
K924661	Baxter Healthcare Corp	SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER	1993-04-08
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014211783. Last updated year: 2026. Please use registration number 3014211783 when referencing this establishment in official correspondence.