Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014598164

FEI Number

3014598164

Entity Name

CAGENT VASCULAR

City/State/Country

Wayne, PA, US

Establishment Address

150 Strafford Avenue, #315, Wayne, PA 19087, US

Establishment Type(s)

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

Owner / Operator

Cagent Vascular (Owner Number: 10060763)

Owner / Operator Contact Address

150 Strafford Avenue, #315, Wayne, PA 19087, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193181

PMA Number

N/A

All Registered Proprietary Names

Serranator PTA Serration Balloon Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2020-10-15

Official Correspondent

Peter Johansson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cagent Vascular

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 3014598164. Last updated year: 2026. Please use registration number 3014598164 when referencing this establishment in official correspondence.