ALPHA MEDICAL INSTRUMENTS LLC

FDA Device Registration & Listing · MISSION VIEJO, CA, US · Registration 3003289723

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
3003289723
FEI Number
3003289723
Entity Name
ALPHA MEDICAL INSTRUMENTS LLC
City/State/Country
MISSION VIEJO, CA, US
Establishment Address
23455 Madero Ste B, MISSION VIEJO, CA 92691, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ALPHA MEDICAL INSTRUMENTS INC (Owner Number: 9034270)
Owner / Operator Contact Address
23455 MADERO, SUITE B, Mission Viejo, CA 92691, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K973639
PMA Number
N/A

All Registered Proprietary Names

Electrophysiology Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2013-01-30

Official Correspondent

Hideo Tanaka

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ALPHA MEDICAL INSTRUMENTS 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
K881966 C.R. Bard, Inc. ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER 1988-10-04
K192037 ABBOTT MEDICAL Advisor VL Circular Mapping Catheter, Sensor Enabled 2019-09-17

Similar Registrations

Registration Number Establishment Name Location
3010273872 Synergy Health AST, SRL Alajuela, CR
3012179728 St. Jude Medical Roseville, MN, US
2182208 MEDTRONIC, INC. Mounds View, MN, US
1319639 Sterigenics U.S., LLC Queensbury, NY, US
1721686 Sterigenics U.S., LLC Santa Teresa, NM, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003289723. Last updated year: 2026. Please use registration number 3003289723 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.