Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029444898

FEI Number

3029444898

Entity Name

ICHOR VASCULAR INC

City/State/Country

Brecksville, OH, US

Establishment Address

7005 South Edgerton Road, Brecksville, OH 44141, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

ICHOR Vascular Inc (Owner Number: 10060126)

Owner / Operator Contact Address

1900 NW 25th Street, Boca Raton, FL 33431, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233917

PMA Number

N/A

All Registered Proprietary Names

iSweep 14F

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2023-10-04
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2024-10-15

Official Correspondent

Timothy Blair

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ICHOR Vascular 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
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
K192036	Inari Medical	ClotTriever Thrombectomy System	2019-08-29

Similar Registrations

Registration Number	Establishment Name	Location
3026567963	ENDOVASCULAR ENGINEERING, INC.	Menlo Park, CA, US
3015924373	AUSA Medical Device Pvt Ltd	Bangalore Karnataka, IN
3017823876	Expanse Medical Inc.	Pleasanton, CA, US
3015615738	Penumbra Inc.	Salt Lake City, UT, US
3020347218	Inari Medical, Inc.	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029444898. Last updated year: 2026. Please use registration number 3029444898 when referencing this establishment in official correspondence.