Data / Medical devices / United States / Mozarc Medical Us LLC
Mozarc Medical Us LLC: FDA-registered device maker in Mansfield, MA, United States, 46 510(k) clearances
Mozarc Medical Us LLC is registered with the FDA (registration 3030574705) in Mansfield, MA, United States. It lists 18 device types. The FDA files 46 510(k) clearances under its listings, the newest dated August 6, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030574705
- Address
- 15 Hampshire Street, Mansfield, MA, United States, 02048
- Owner or operator
- Mozarc Medical US LLC (10090982)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 29, 2024
- Registered through
- 2026
- Brand names listed
- Acute and Chronic Catheter Repair Kit, Chameleon PTA Balloon, Chameleon PTA Balloon Catheter, Chameleon PTA Balloon Catheter with Injection Port, MAHURKAR Acute Dual Lumen Catheters, Kits, and Trays, MAHURKAR Acute Dual Lumen High Flow Catheter Kits and Trays, MAHURKAR Acute High Pressure Triple Lumen Catheter, Kits, and Trays, MAHURKAR Acute Triple Lumen Catheter, Kits, and Trays and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 6, 2026 | K253469 | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | FIE | Substantially Equivalent | Mozarc Medical Us, LLC | accessdata.fda.gov |
| January 14, 2022 | K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit | FJS | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| January 17, 2020 | K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter | MPB | Unknown | Covidien, LLC | accessdata.fda.gov |
| July 27, 2018 | K180485 | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender | FJS | Unknown | Covidien, LLC | accessdata.fda.gov |
| March 30, 2017 | K170635 | Chameleon PTA Balloon Catheter | LIT | Substantially Equivalent | Av Medical Technologies, Ltd. | accessdata.fda.gov |
| January 17, 2017 | K163231 | Chameleon PTA Balloon Catheter | LIT | Substantially Equivalent | Av Medical Technologies, Ltd. | accessdata.fda.gov |
| September 21, 2015 | K151678 | Chameleon PTA Balloon Catheter | LIT | Substantially Equivalent | Av Medical Technologies, Ltd. | accessdata.fda.gov |
| January 31, 2013 | K123196 | PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH | MSD | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 21, 2012 | K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM | MSD | Unknown | Medical Components, Inc. | accessdata.fda.gov |
| April 4, 2012 | K120674 | MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER | MPB | Unknown | Covidien | accessdata.fda.gov |
| September 28, 2011 | K112477 | PALINDROME H, SI, HSI CHRONIC CATHETER | NYU | Unknown | Covidien | accessdata.fda.gov |
| August 30, 2011 | K111817 | PALINDROME RT CHRONIC CATHETER | MSD | Unknown | Covidien | accessdata.fda.gov |
| August 4, 2011 | K111372 | TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... | MSD | Unknown | Covidien | accessdata.fda.gov |
| December 22, 2010 | K102605 | MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER | NIE | Unknown | Covidien, LLC, Formerly Registered AS Tyco Healthca | accessdata.fda.gov |
| November 19, 2009 | K092797 | ACUTE AND CHRONIC CATHETER REPAIR KIT | NFK | Unknown | Kendall | accessdata.fda.gov |
| October 30, 2009 | K092205 | PALINDROME P HEMODIALYSIS CATHETER | MSD | Unknown | Covidien Lp, Formerly Registered AS Kendall | accessdata.fda.gov |
| May 19, 2004 | K041006 | TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR | MSD | Substantially Equivalent | Kendall | accessdata.fda.gov |
| May 13, 2003 | K030209 | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR | MPB | Substantially Equivalent | The Kendall Company | accessdata.fda.gov |
| April 10, 2002 | K020089 | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR | NIE | Substantially Equivalent | The Kendall Company | accessdata.fda.gov |
| April 9, 2001 | K002902 | TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS | MSD | Substantially Equivalent | The Kendall Company | accessdata.fda.gov |
| November 25, 1998 | K981365 | MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS | MSD | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| December 15, 1995 | K950042 | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| March 22, 1995 | K943349 | MAHURKAR DUAL LUMEN CATHETER | FOZ | Unknown | Quinton, Inc. | accessdata.fda.gov |
| May 4, 1992 | K920515 | INSERTION | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| September 19, 1991 | K910786 | TROCAR (FALLER STYLET) | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| August 22, 1991 | K910785 | TITANIUM CATHETER EXTENDER | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| August 15, 1991 | K910787 | TITANIUM CONNECTOR (2 PART) | FKO | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| January 29, 1990 | K896252 | MODIFIED QUINTON SINGLE LUMEN CATHETER | MPB | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| March 27, 1989 | K890288 | PERITONEAL CATHETERS WITH AN ADDED FUNCTION | FJS | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| February 17, 1988 | K874633 | PERMCATH INSERTION TRAY | LFJ | Unknown | Quinton, Inc. | accessdata.fda.gov |
| October 7, 1987 | K873727 | PULL-APART INTRODUCER (SHEATH) | DYB | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| September 30, 1987 | K873394 | OVAL PULL-APART SHEATH/DILATOR | DYB | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| June 17, 1987 | K871942 | PERM-CATH CATHETER KIT | LFJ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| June 17, 1987 | K871749 | ADULT PERM-CATH 40CM. | LFJ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| May 18, 1987 | K871730 | MODIFIED USE OF PULL-APART INTRODUCER SET | FKO | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| August 19, 1986 | K862288 | MODIFICATION OF TISSUE DILATOR | DRE | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| June 19, 1986 | K862046 | SWAN-NECK PERITONEAL DIALYSIS CATHETERS | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| July 26, 1985 | K850214 | STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| May 17, 1985 | K844193 | QUINTON INJECTION SEALING CAP | FOZ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| January 18, 1985 | K844692 | PEDIATRIC SIZED HEMOCATH CATHETER | FIQ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| November 8, 1984 | K840815 | LUER LOCKING ADAPTER(MATERIAL CHANGE) | FOZ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| April 20, 1984 | K840415 | HEMOCATH | FIQ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| March 5, 1984 | K840424 | HEMOCATH REPAIR KIT | KNZ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| December 31, 1981 | K813488 | CATHETER REGULAR | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| May 16, 1978 | K780449 | BETA CAP SYSTEM | FJS | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| June 14, 1977 | K770977 | CARDIOVASCULAR SPRING GUIDES | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 29, 2026 | 98891 | Class II | Ongoing | Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tr | The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays. | accessdata.fda.gov |
| October 17, 2025 | 97848 | Class II | Ongoing | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm | A potential issue with the seal integrity of header bag packaging. | accessdata.fda.gov |
| April 23, 2025 | 96809 | Class II | Ongoing | Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Potential breach of sterile barrier packaging. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Hemodialysis, Implanted
- All makers of Catheter, Peritoneal Dialysis, Single Use
- All makers of Catheter, Peritoneal, Long-Term Indwelling
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Kit, Repair, Catheter, Hemodialysis
- All makers of Catheter, Subclavian
Updated August 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.