MERIL INC

FDA Device Registration & Listing · Bethlehem, PA, US · Registration 3012167431

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
3012167431
FEI Number
3012167431
Entity Name
MERIL INC
City/State/Country
Bethlehem, PA, US
Establishment Address
2436 Emrick Boulevard, Bethlehem, PA 18020, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Meril Inc (Owner Number: 10049695)
Owner / Operator Contact Address
2436 Emrick Boulevard, Bethlehem, PA 18020, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K172737
PMA Number
N/A

All Registered Proprietary Names

Mozec(TM) Rx PTCA Balloon Dilatation Catheter MESIRE Light Guide Cable MESIRE™ - Balloon Sinus Dilatation 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 2019-12-06
EQH Source, Carrier, Fiberoptic Light Ear, Nose, Throat Class 1 874.4350 2018-12-31
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2018-12-31

Official Correspondent

Kaiyumkhan Patel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Meril 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
K143738 Intuit Medical Products, LLC DSS Sinusplasty Balloon Catheter 2015-08-27

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 3012167431. Last updated year: 2026. Please use registration number 3012167431 when referencing this establishment in official correspondence.
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