Atlas FDA

FJG

36 FDA 510(k) clearances · Product code

63 daysmedian time to decision
169 days90th percentile
36clearances measured

FDA profile

Official device name
Dialyzer, Parallel Flow
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Adverse events (MAUDE)
1995: 3 · 1996: 65 · 1997: 5 · 1998: 6 · 1999: 17 · 2000: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS (K933681)Cobe Renal Care, Inc.1994-09-07
GAMBRO LUNDIA PRO 200 DIALYZER (K933680)Cobe Renal Care, Inc.1994-08-26
DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (K920693)National Medical Care, Medical Products Div., Inc.1992-09-21
GAMBRO LUNDIA ALPHA HEMODIALYZERS (K915504)C.G.H. Medical, Inc.1992-03-06
HEMOSPAL KITS A1, A2D, AO, & A1D (K901368)Gambro-Hospal, Inc.1990-08-02
TENCKHOFF PERITONEAL DIALYSIS KIT (K902203)Akcess Medical Products, Inc.1990-08-01
GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N (K862840)Gambro, Inc.1986-09-29
GAMBRO LUNDIA PRO 3 & 5 DIALYZER (K853406)Gambro, Inc.1986-01-08
COBE PPD 1.3L, #18-520-009 (K820694)Cobe Laboratories, Inc.1982-03-31
COBE PPD 1.9 (K812336)Cobe Laboratories, Inc.1981-08-31
EXP 200 PARALLEL PLATE DIALYZER (K811439)Extracorporeal Medical Specialities, Inc.1981-06-12
EXP 600 PARALLEL PLATE DIALYZER (K811440)Extracorporeal Medical Specialities, Inc.1981-06-12
COBE PPD .8 (K810066)Cobe Laboratories, Inc.1981-06-09
CYBER 80 HEMODIALYZER (K810837)Cyberex Corp.1981-05-05
CYBER 120 HEMODIALYZER (K802478)Cyberex Corp.1981-03-20
NIKKISO ND-14 PARALLEL FLOW DIALYZER (K803068)NIKKISO CO., LTD.1981-03-04
EXTRACORPOREAL'S EXP 400 PARALLEL PLATE (K802364)Extracorporeal Medical Specialities, Inc.1981-01-29
GAMBRO LUNDIA PLATE DISP. DIALYZER (K802389)Gambro, Inc.1980-12-22
THE BRAVO NEW PARALLEL FLOW DIALYZER (K801633)Bellco Artifidial Organ Spec., Inc.1980-12-18
ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM (K801451)Medical, Inc.1980-09-26
CYBER 120 HEMODIALYZER (K801377)Cyberex Corp.1980-08-27
LUNDIA PLATE DISP. (K800424)Gambro, Inc.1980-04-10
GAMBRO LUNDIA PLATE DIALYZER (K792611)Gambro, Inc.1980-02-06
EXTRACORPOREAL'S MODEL EX-85 DIALYZER (K791961)Extracorporeal Medical Specialities, Inc.1979-11-13
HEMODIALYZERS RP-510 AND RP-514 (K791448)Hospal Medical Corp.1979-08-07
HEMOCLEAR U-NEPHROS 1.0 DIALYZER (K790758)Medical, Inc.1979-05-08
HD CAPILLARY FILM DIALYZER, MODEL 1001 (K790533)Travenol Laboratories, S.A.1979-05-02
DIALYZER, MODEL F.M.D 150 (K790001)Hospal Medical Corp.1979-03-06
DIALYZER, MAGNIFLO 100 PARALLEL PLATE (K781966)Erika, Inc.1979-02-21
DIALYZER, PARALLEL FLOW DISPOSABLE (K781795)Medical, Inc.1978-12-15
LUNDIA PLATE DISPOSABLE DIALYZER (K780700)Gambro, Inc.1978-07-17
RP-510/RP-514 PARALLEL PLATE DIALYZERS (K780427)Hospal Medical Corp.1978-05-19
DIALYZER STANDARD, CODE 5DM1780 (K772318)Travenol Laboratories, S.A.1978-01-26
PARALLEL PLATE DIALYZERS (K771354)Hospal Medical Corp.1977-09-15
DIALYZER, ULTRADIFFUSER, DISPOSABLE (K770858)Gambro, Inc.1977-06-14
PARALLEL PLATE DIALYZER (K770578)Cobe Laboratories, Inc.1977-04-15

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