Atlas FDA

TORAY FILTRYZER DIALYZERS

FDA 510(k) clearance K884339 · decided 1989-03-17

Clearance details

K-number
K884339
Device name
TORAY FILTRYZER DIALYZERS
Applicant
Toray Industries (America), Inc.
Decision
Substantially Equivalent
Date received
1988-10-14
Decision date
1989-03-17
Days to decision
154 days
Clearance type
Traditional
Product code
FJI
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
New York, NY, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Toray Industries (America)

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
INOUE BALLOON CATHETER (P910054/S010)Toray Industries (America), Inc.2024-07-01
Inoue-Balloon Catheter (P910054/S009)Toray Industries (America), Inc.2024-05-24
INOUE-BALLOON Catheter (P910054/S008)Toray Industries (America), Inc.2021-08-31
Inoue Balloon Catheter (P910054/S007)Toray Industries (America), Inc.2020-03-30
Toray Inoue Balloon Catheter (P910054/S006)Toray Industries (America), Inc.2018-09-13
TORAY INOUE BALLOON CATHETER (P910054/S005)Toray Industries (America), Inc.2011-05-17
TORAY INOUE BALLON CATHETER (P910054/S004)Toray Industries (America), Inc.2007-07-03
INOUE BALLOON CATHETER (P910054/S002)Toray Industries (America), Inc.2002-02-13