Atlas FDA

CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY

FDA 510(k) clearance K802894 · decided 1981-02-19

Clearance details

K-number
K802894
Device name
CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
1980-11-17
Decision date
1981-02-19
Days to decision
94 days
Clearance type
Traditional
Product code
FJI
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Walker, MI, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Cordis Corp.

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
Hemoflow F3 and F4 Dialyzers (K190459)Fresenius Medical Care Renal Therapies Group, LLC2019-08-23
NIPRO PUREFLUX-L HEMODIALYZER (K122952)Nipro Medical Corporation2013-12-04
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR (K043342)Gambro Renal Products2005-05-27
DISPOSABLE STORAGE CAP (K010366)Molded Products, Inc.2001-11-28
ULTRACONCENTRATOR SYSTEM (K011148)Interpore Cross Intl.2001-06-13
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (K002761)Fresenius Medical Care North America2000-12-04
IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (K991908)Idemsa2000-04-17
A-15 HEMODIALYZER (K992594)Althin Medical AB1999-09-24
A-18 HEMODIALYZER (K992565)Althin Medical AB1999-09-23
ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (K991512)Asahi Medical Co., Ltd.1999-07-29
DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 (K990159)Dynamic Technology Corp.1999-04-19
CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER (K982337)Haidylena Medical Egypt1998-12-29

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086)Cordis Corp.2014-10-10
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082)Cordis Corp.2012-01-27
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085)Cordis Corp.2012-01-26
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059)Cordis Corp.2011-05-27
CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083)Cordis Corp.2011-05-27
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081)Cordis Corp.2011-03-03
CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026)Cordis Corp.2011-02-22
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078)Cordis Corp.2010-09-02