Atlas FDA

Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit

FDA 510(k) clearance K213602 · decided 2022-01-14

Clearance details

K-number
K213602
Device name
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
Applicant
Covidien, LLC
Decision
Substantially Equivalent
Date received
2021-11-15
Decision date
2022-01-14
Days to decision
60 days
Clearance type
Traditional
Product code
FJS
Device class
2
Regulation number
876.5630
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

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
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 (K180485)Covidien, LLC2018-07-27
FALLER STYLET (K130441)Medionics International, Inc.2013-04-19
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) (K121383)Medical Components, Inc.2012-09-05
FALLER TROCAR (K120130)Medigroup, Inc.2012-05-21
VETA PERITONEAL DIALYSIS CATHETER (K113354)Pfm Medical, Inc.2012-03-13
FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 (K071167)Medigroup, Inc.2007-08-31
FLEX-NECK ARC CATHETER (K070730)Medigroup, Inc.2007-07-03
EMBEDDING TOOL, MODEL TE-1000 (K060897)Medigroup, Inc.2006-07-18
PD CATH (K053123)Med-Conduit, Inc.2006-03-29
FLEX-NECK PD CATHETER, INFANT (K031351)Medigroup, Inc.2003-09-17
MEDIGROUP CATHETER EXTENDER/REPAIR KIT (K012502)Janin Group, Inc.2002-02-04
MEDIGROUP KEY TUBE (K013017)Janin Group, Inc.2001-12-06

Recalls involving this device

No recalls on record reference this clearance.

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