Atlas FDA

LIFECOIL CATHETER

FDA 510(k) clearance K903502 · decided 1990-10-22

Clearance details

K-number
K903502
Device name
LIFECOIL CATHETER
Applicant
Lifemed of California
Decision
Substantially Equivalent
Date received
1990-08-03
Decision date
1990-10-22
Days to decision
80 days
Clearance type
Traditional
Product code
FJS
Device class
2
Regulation number
876.5630
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Compton, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Lifemed of California

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 Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit (K213602)Covidien, LLC2022-01-14
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, 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

Recalls involving this device

No recalls on record reference this clearance.