Atlas FDA

Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter

FDA 510(k) clearance K192302 · decided 2020-01-17

Clearance details

K-number
K192302
Device name
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
Applicant
Covidien, LLC
Decision
Unknown
Date received
2019-08-23
Decision date
2020-01-17
Days to decision
147 days
Clearance type
Traditional
Product code
MPB
Device class
2
Regulation number
876.5540
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mansfield, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Covidien

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
14F Duo-Flow® Side X Side Double Lumen Catheter (K250836)Medical Components, Inc.2025-08-12
Acute Dual Lumen Hemodialysis Catheter (K200426)Health Line International Corporation2020-12-24
Duo-Flow Side x Side Double Lumen Catheter (K192807)Medical Components, Inc. (dba MedComp)2020-04-23
Zenysis Short-Term Dialysis Catheter (K163458)C.R. Bard, Inc.2017-04-04
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray (K161504)Cook Incorporated2017-01-06
Zenysis Short-Term Dialysis Catheter (K153190)C.R. Bard, Inc.2016-01-05
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY (K122091)Cook, Inc.2013-07-29
MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER (K120674)Covidien2012-04-04
AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS (K110793)Ameco Medical Industries2011-12-16
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS (K102833)Foshan Nanhai Bai HE Medical Technology Co., Ltd.2011-11-18
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 (K100451)Gambro Renal Products, Inc.2010-12-21
NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS (K090102)C.R. Bard, Inc.2009-02-12

Recalls involving this device

RecordFirmDate
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Compone recall (Z-0421-2026)Mozarc Medical US LLC2025-11-04
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Compone recall (Z-0422-2026)Mozarc Medical US LLC2025-11-04
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Compone recall (Z-0423-2026)Mozarc Medical US LLC2025-11-04
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Compo recall (Z-0424-2026)Mozarc Medical US LLC2025-11-04
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Compo recall (Z-0425-2026)Mozarc Medical US LLC2025-11-04
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safet recall (Z-0426-2026)Mozarc Medical US LLC2025-11-04

PMA approvals by this applicant

RecordFirmDate
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S012)Covidien, LLC2005-06-24
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S011)Covidien, LLC2005-02-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S006)Covidien, LLC2003-01-07
OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S009)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S008)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S010)Covidien, LLC2002-11-15
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S005)Covidien, LLC2002-06-28
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S007)Covidien, LLC2002-04-18