Atlas FDA

ALTERNATE STERILIZ. FOR CELLULOSE ACET

FDA 510(k) clearance K810315 · decided 1981-03-20

Clearance details

K-number
K810315
Device name
ALTERNATE STERILIZ. FOR CELLULOSE ACET
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
1981-02-05
Decision date
1981-03-20
Days to decision
43 days
Clearance type
Traditional
Product code
FKQ
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
DIACAP ULTRA DIALYSIS FLUID FILTER (K052764)B. Braun Medizintechnologie GmbH2006-06-09
TWO TANK DISSOLUTION MODULE (K893612)National Medical Care, Medical Products Div., Inc.1989-07-24
MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM (K874084)National Medical Care, Medical Products Div., Inc.1988-04-27
KAWASUMI A.V. FISTULA SET (K873421)Kawasumi Laboratories Co., Ltd.1987-10-09
ACID FUCHSIN SOLUTIONS (K870889)D.R.G. Scientific Industries1987-07-08
ACTRIL FOR KIDNEY MACHINE DISINFECTANT (K861730)Renal Systems, Inc.1987-06-09
FOUR TANK DISSOLUTION MODULE (K864635)National Medical Care, Medical Products Div., Inc.1987-01-13
DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM (K862304)Cd Medical, Inc.1986-09-09
MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 (K861472)National Medical Care, Medical Products Div., Inc.1986-07-10
AMUCHINA/DIALYZER DISINFECTANT (K852359)Amuchina Intl., Inc.1986-05-13
HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS (K860336)Breem Laboratories1986-03-04
HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES (K860297)Renal Hygienics1986-03-04

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