510(k) K121383
- Device
- PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
- Applicant
- MEDICAL COMPONENTS INC
- 510(k) number
- K121383
- Product code
- FJS
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 2012-09-05
- Date received
- 2012-05-08
- Regulation
- 876.5630
- Classification name
- Catheter, Peritoneal, Long-term Indwelling
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEAN CALLOW
- Address
- 1499 Delp Dr. Harleysville PA US 19438 19438
FDA Registration Numbers#
- 3013666218
- 2527072
- 9611665
- 3007544634
- 3015309643
- 3010665433
- 3006950086
- 2529647
- 3033589330
- 3009211636
- 3030574705
- 2518902
- 1721676
- 1721504
- 9611088
- 1724474
- 9610849
- 2030624
- 3007207906
- 2011171
- 1833566
- 3015225571
- 1319639
- 3012536737
- 1282497
- 3003915875
Source Documents#
Other 510(k) Records For Product Code FJS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit | Covidien, LLC | 2022-01-14 |
| 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 | Covidien, LLC | 2018-07-27 |
| K130441 | FALLER STYLET | Medionics International, Inc. | 2013-04-19 |
| K120130 | FALLER TROCAR | Medigroup, Inc. | 2012-05-21 |
| K113354 | VETA PERITONEAL DIALYSIS CATHETER | Pfm Medical, Inc. | 2012-03-13 |
| K071167 | FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 | Medigroup, Inc. | 2007-08-31 |
| K070730 | FLEX-NECK ARC CATHETER | Medigroup, Inc. | 2007-07-03 |
| K060897 | EMBEDDING TOOL, MODEL TE-1000 | Medigroup, Inc. | 2006-07-18 |
| K053123 | PD CATH | Med-Conduit, Inc. | 2006-03-29 |
| K031351 | FLEX-NECK PD CATHETER, INFANT | Medigroup, Inc. | 2003-09-17 |
| K012502 | MEDIGROUP CATHETER EXTENDER/REPAIR KIT | Janin Group, Inc. | 2002-02-04 |
| K013017 | MEDIGROUP KEY TUBE | Janin Group, Inc. | 2001-12-06 |
| K993149 | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS | Medionics International, Inc. | 2000-04-28 |
| K991042 | ASH ADVANTAGE PERITONEAL CATHETER | Janin Group, Inc. | 1999-06-25 |
| K970159 | FLEX-NECK PD CATHETER | Janin Group, Inc. | 1997-09-05 |
Legacy Summary#
summary
FDA Review#
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