VIZARAMED, INC.

FDA Device Registration & Listing · San Jose, CA, US · Registration 3027366703

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027366703
FEI Number
3027366703
Entity Name
VIZARAMED, INC.
City/State/Country
San Jose, CA, US
Establishment Address
1914 O'Toole Way, San Jose, CA 95131, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
VIzaramed, Inc. (Owner Number: 10088098)
Owner / Operator Contact Address
1914 O'Toole Way, San Jose, CA 95131, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K221655
PMA Number
N/A

All Registered Proprietary Names

Multiflex Multiflex

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2026-05-12
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-05-24

Official Correspondent

Raj Subramaniam

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VIzaramed, 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
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26
K122854 Arrow International (Subsidiary of Teleflex Inc.) ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 2013-01-04
K233691 Acutus Medical, Inc. FlexCath Cross Transseptal Solution 2023-12-17
K915078 North American Instrument Corp. MORSE HEMOSTATIC CATHETER INTRODUCER SET 1992-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027366703. Last updated year: 2026. Please use registration number 3027366703 when referencing this establishment in official correspondence.
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