Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008700817

FEI Number

3008700817

Entity Name

Verge Medical Inc.

City/State/Country

Campbell, CA, US

Establishment Address

747 Camden Ave Ste A, Campbell, CA 95008, US

Establishment Type(s)

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

Owner / Operator

Verge Medical Inc. (Owner Number: 10034123)

Owner / Operator Contact Address

747 Camden Ave, STE A, Campbell, CA 95008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131450

PMA Number

N/A

All Registered Proprietary Names

Ostial Corporation/Verge Medical Inc./FLASH MINI Ostial System FLASH MINI Ostial System FLASH Ostial System Ostial Corporation/Verge Medical Inc./Flash Ostial System FLASH Flex Aorto-Ostial Angioplasty System FLASH Ostial System Ostial Corporation/Verge Medical Inc./Flash Ostial System RoVo Mechanical Thrombectomy System FLASH Ostial System OTW Ostial Corporation/Verge Medical Inc./FLASH Ostial System OTW FLASH MINI Ostial System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2016-03-31
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-07-26
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2026-04-20
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-10-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2026-01-23
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2026-01-23
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2015-06-09
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2013-08-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Verge Medical 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
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008700817. Last updated year: 2026. Please use registration number 3008700817 when referencing this establishment in official correspondence.