Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020031299

FEI Number

3020031299

Entity Name

ENSITEVASCULAR, LLC

City/State/Country

Overland Park, KS, US

Establishment Address

10561 Barkley St Ste 610, Overland Park, KS 66212, US

Establishment Type(s)

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

Owner / Operator

EnsiteVascular, LLC (Owner Number: 10082533)

Owner / Operator Contact Address

10561 Barkley St., Ste 610, Overland Park, KS 66212, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192413

PMA Number

N/A

All Registered Proprietary Names

SiteSeal 01

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2021-08-10

Official Correspondent

Thomas Reidy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EnsiteVascular, LLC

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020031299. Last updated year: 2026. Please use registration number 3020031299 when referencing this establishment in official correspondence.