MOZARC MEDICAL US LLC

FDA Device Registration & Listing · Mansfield, MA, US · Registration 3030574705

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
3030574705
FEI Number
3030574705
Entity Name
MOZARC MEDICAL US LLC
City/State/Country
Mansfield, MA, US
Establishment Address
15 Hampshire Street, Mansfield, MA 02048, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Mozarc Medical US LLC (Owner Number: 10090982)
Owner / Operator Contact Address
15 Hampshire Street, Mansfield, MA 02048, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K102605
PMA Number
N/A

All Registered Proprietary Names

Ritus™ Peritoneal Dialysis Catheter Tunneling Tool Kit Ritus Introducer Needle Ritus Peritoneal Dialysis Catheter Kit Chameleon PTA Balloon Catheter with Injection Port Tandem-Cath Chronic Dual Catheter System Repair Kit Ritus Peritoneal Dialysis Accessory Permcath Pediatric Chronic Silicone Oval Catheter Kit Ritus Peritoneal Dialysis Accessory Ritus Peritoneal Dialysis Accessories MAHURKAR Elite Acute Triple Lumen Catheters, Kits, and Trays Permcath Pediatric Chronic Silicone Oval Catheter Tray Permcath Chronic Silicone Oval Catheter Palindrome HSI Chronic Catheter Kits and Sport Packs Pull Apart Introducer Sets Add device listing Palindrome RT Chronic Catheter Kit Chameleon PTA Balloon Palindrome Chronic Catheter Kits and Sport Packs Ritus Peritoneal Dialysis Catheter Kit Ritus Peritoneal Dialysis Accessory Oval Pull Apart Set Ritus Peritoneal Dialysis Accessory Titanium Connector Permcath Chronic Silicone Oval Catheter MAHURKAR Acute Triple Lumen Catheter, Kits, and Trays Acute and Chronic Catheter Repair Kit Mahurkar Acute Single Lumen Catheters and Kits MAHURKAR Chronic Silicone Catheter Kits and Trays Ritus Peritoneal Dialysis Accessory Extender MAHURKAR Acute Dual Lumen Catheters, Kits, and Trays MAHURKAR Acute Dual Lumen High Flow Catheter Kits and Trays Ritus Peritoneal Dialysis Accessory 8 Fr Dilator Ritus Dialysis Catheter Accessories Tandem-Cath Chronic Dual Catheter System Ritus Peritoneal Dialysis Catheter Kit Palindrome RT Repair Kit MAHURKAR Acute High Pressure Triple Lumen Catheter, Kits, and Trays

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2024-07-29
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2024-07-29
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2024-07-29
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2024-07-29
LFJ Catheter, Subclavian Gastroenterology, Urology Class 2 876.5540 2024-07-29
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2024-07-29
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2024-07-29
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
LFJ Catheter, Subclavian Gastroenterology, Urology Class 2 876.5540 2024-07-29
LFJ Catheter, Subclavian Gastroenterology, Urology Class 2 876.5540 2024-07-29
NYU Catheter, Hemodialysis, Implanted, Coated Gastroenterology, Urology Class 2 876.5540 2024-07-29
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
FKO Catheter, Peritoneal Dialysis, Single Use Gastroenterology, Urology Class 2 876.5630 2024-07-29
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2024-07-29
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2024-07-29
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-07-29
FKO Catheter, Peritoneal Dialysis, Single Use Gastroenterology, Urology Class 2 876.5630 2024-07-29
FIQ Cannula, A-V Shunt Gastroenterology, Urology Class 2 876.5540 2024-07-29
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
NFK Kit, Repair, Catheter, Hemodialysis Gastroenterology, Urology Class 2 876.5540 2024-07-29
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2024-07-29
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2024-07-29
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2024-07-29
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2024-07-29
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2024-07-29
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29
NFK Kit, Repair, Catheter, Hemodialysis Gastroenterology, Urology Class 2 876.5540 2024-07-29
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2024-07-29

Official Correspondent

Carol Ming

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mozarc Medical US LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1000312731 BELLCO Srl Mirandola Modena, IT
3043804021 Mozarc Medical Italy Mirandola Modena, IT

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K171618 Medcomp (Dba Medical Components, Inc.) Symetrex Long Term Hemodialysis Catheter 2017-11-16
K111817 Covidien PALINDROME RT CHRONIC CATHETER 2011-08-30
K171251 Creagh Medical 014 Hydrophilic Coated PTA Balloon Dilatation Catheter 2017-09-08
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K252512 ABBOTT MEDICAL Armada™ 14 NC PTA Catheter 2026-02-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0329-2016 Covidien LLC 2
Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Z-0330-2016 Covidien LLC 2
Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Z-0331-2016 Covidien LLC 2
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Z-0332-2016 Covidien LLC 2
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Z-0333-2016 Covidien LLC 2
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030574705. Last updated year: 2026. Please use registration number 3030574705 when referencing this establishment in official correspondence.
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