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
FDA 510(k) clearance K180485 · decided 2018-07-27
Clearance details
- K-number
- K180485
- Device name
- 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
- Applicant
- Covidien, LLC
- Decision
- Unknown
- Date received
- 2018-02-23
- Decision date
- 2018-07-27
- Days to decision
- 154 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
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Similar devices under this product code
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 |
| 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
| Record | Firm | Date |
|---|---|---|
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S012) | Covidien, LLC | 2005-06-24 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S011) | Covidien, LLC | 2005-02-25 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S006) | Covidien, LLC | 2003-01-07 |
| OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S009) | Covidien, LLC | 2002-11-25 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S008) | Covidien, LLC | 2002-11-25 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S010) | Covidien, LLC | 2002-11-15 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S005) | Covidien, LLC | 2002-06-28 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S007) | Covidien, LLC | 2002-04-18 |