PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)

FDA 510(k) clearance K121383 · decided 2012-09-05

Clearance details

K-number: K121383
Device name: PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
Applicant: Medical Components, Inc.
Decision: Unknown
Date received: 2012-05-08
Decision date: 2012-09-05
Days to decision: 120 days
Clearance type: Traditional
Product code: FJS
Device class: 2
Regulation number: 876.5630
Medical specialty: Gastroenterology, Urology
Advisory committee: Gastroenterology, Urology
Location: Harleysville, PA, US
Third-party review: No
Expedited review: No

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

Record	Firm	Date
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit (K213602)	Covidien, LLC	2022-01-14
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, LLC	2018-07-27
FALLER STYLET (K130441)	Medionics International, Inc.	2013-04-19
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

No recalls on record reference this clearance.