Atlas FDA

DIALYSATE DELIVERY SYSTEM

FDA 510(k) clearance K781886 · decided 1979-01-17

Clearance details

K-number
K781886
Device name
DIALYSATE DELIVERY SYSTEM
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
1978-11-07
Decision date
1979-01-17
Days to decision
71 days
Clearance type
Traditional
Product code
FKP
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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CKHEMO, MODEL CKHEMO VERSION 1.0 (K992255)Csam, Inc.1999-11-30
HIGH RANGE PEROXIDE TEST STRIP (K964264)Integrated Biomedical Technology, Inc.1997-06-16
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (K955423)Fresenius USA, Inc.1996-06-13
WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE (K953854)Integrated Biomedical Technology, Inc.1996-03-11
BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (K930181)Fresenius USA, Inc.1995-11-29
SPS 1550 SINGLE NEEDLE PATIENT SYSTEM (K922757)Baxter Healthcare Corp1995-02-13

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