Atlas FDA

DISSCAP 110

FDA 510(k) clearance K820966 · decided 1982-04-16

Clearance details

K-number
K820966
Device name
DISSCAP 110
Applicant
Hospal Medical Corp.
Decision
Substantially Equivalent
Date received
1982-04-06
Decision date
1982-04-16
Days to decision
10 days
Clearance type
Traditional
Product code
FKQ
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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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.