Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014498720

FEI Number

3014498720

Entity Name

VESALIO

City/State/Country

San Diego, CA, US

Establishment Address

2305 Historic Decatur Rd, Suite 100, San Diego, CA 92106, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Vesalio, Inc (Owner Number: 10057432)

Owner / Operator Contact Address

5800 Granite Parkway, Suite 470, Plano, TX 75024, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

H210004

All Registered Proprietary Names

pVasc Aspiration Catheter System NeVa pVasc Thrombectomy Device VP-6035-F2RR NeVa pVasc Thrombectomy Device VP-4537-F2RR NeVa pVasc Thrombectomy Device VP-4038-F3RX NeVa pVasc Thrombectomy Device VP-4030-F2RR NeVa pVasc Thrombectomy Device VP-4022-02RX NeVa pVasc Thrombectomy Device VP-4546-F3RX NeVa pVasc Thrombectomy Device VP-6044-F3RR NeVa pVasc Thrombectomy Device VP-4038-F3RR NeVa pVasc Thrombectomy Device VP-4537-F2RX NeVa pVasc Thrombectomy Device VP-4544-05RR NeVa pVasc Thrombectomy Device VP-4546-F3RR NeVa pVasc Thrombectomy Device VP-4030-F2RX NeVa pVasc Thrombectomy Device VP-4022-02RR NeVa pVasc Thrombectomy Device VP-4529-03RX NeVa pVasc Thrombectomy Device VP-4529-03RR NeVa VSx NeVa M1-Sx NeVa VS NeVa M1-S NeVa M1 NeVa M1x NeVa Tx NeVa T enVast Coronary Thrombectomy System NeVasc Aspiration System NeVa VS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2026-03-18
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2024-04-01
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2024-04-01
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2018-04-06
QEX	Coronary Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2026-03-18
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2026-03-18
QTK	Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device	Unknown	Class f	N/A	2022-09-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vesalio, Inc

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
K232458	ABBOTT MEDICAL	JETiHydrodynamic Thrombectomy System	2023-12-19
K243549	ABBOTT MEDICAL	JETi Hydrodynamic Thrombectomy System	2025-04-04
K241362	Surmodics,Inc.	Pounce XL Thrombectomy System (PTS-1011-7F135)	2024-09-11
K220887	Inari Medical	Mini-ClotTriever Thrombectomy System	2022-08-04
K250421	Inari Medical, Inc.	InThrill Thrombectomy System	2025-05-12

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014498720. Last updated year: 2026. Please use registration number 3014498720 when referencing this establishment in official correspondence.