Atlas FDA

ULTRACON ULTRAFILTRATOR

FDA 510(k) clearance K981253 · decided 1998-12-11

Clearance details

K-number
K981253
Device name
ULTRACON ULTRAFILTRATOR
Applicant
Interpore Intl.
Decision
Substantially Equivalent
Date received
1998-04-06
Decision date
1998-12-11
Days to decision
249 days
Clearance type
Traditional
Product code
FJI
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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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
PRO OSTEON 500 BONE GRAFT SUBSTITUTE (P860005/S012)Interpore Intl.2002-05-31
PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES (P860005/S011)Interpore Intl.1999-05-25
PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES (P860005/S009)Interpore Intl.1998-04-28
PRO OSTEON IMPLANT 500 POROUS CORALLINE HYDROXYAPATITE BONE GRAFT SUBSTITUTE (P860005/S010)Interpore Intl.1998-01-08
PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S008)Interpore Intl.1997-09-11
PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S007)Interpore Intl.1997-05-30
PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S005)Interpore Intl.1996-07-18
INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX (P860005/S004)Interpore Intl.1994-08-08