The Bravo New Parallel Flow Dialyzer

FDA 510(k) K801633 · Bellco Artifidial Organ Spec., Inc.

Substantially Equivalent

510(k) numberK801633

Submission

Device name
The Bravo New Parallel Flow Dialyzer
Applicant
Bellco Artifidial Organ Spec., Inc.
Mchenry, IL, US
Received
July 15, 1980
Decision date
December 18, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FJG – Dialyzer, Parallel Flow
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

Other 510(k)s with product code FJG

510(k)DeviceApplicantDecision
K933681Gambro Lundia Pro 100, 500, 600 DialyzersFJG · Traditional Cobe Renal Care, Inc.09/07/1994SE
K933680Gambro Lundia Pro 200 DialyzerFJG · Traditional Cobe Renal Care, Inc.08/26/1994SE
K920693Dextrolyte II Peritoneal Dialysis 48-3028-9FJG · Traditional National Medical Care, Medical Products Div., Inc.09/21/1992SE
K915504Gambro Lundia Alpha HemodialyzersFJG · Traditional C.G.H. Medical, Inc.03/06/1992SE
K901368Hemospal Kits A1, A2D, Ao, & A1DFJG · Traditional Gambro-Hospal, Inc.08/02/1990SE
K902203Tenckhoff Peritoneal Dialysis KitFJG · Traditional Akcess Medical Products, Inc.08/01/1990SESK
K862840Gambro Lundia 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6NFJG · Traditional Gambro, Inc.09/29/1986SE
K853406Gambro Lundia Pro 3 & 5 DialyzerFJG · Traditional Gambro, Inc.01/08/1986SE
K820694Cobe PPD 1.3L, #18-520-009FJG · Traditional Cobe Laboratories, Inc.03/31/1982SE
K812336Cobe PPD 1.9FJG · Traditional Cobe Laboratories, Inc.08/31/1981SE

More from Cobe Laboratories, Inc.

510(k)DeviceDecision
K801634The Vita 2 Disposable DialyzerFHS · Traditional 12/17/1980SE
K801632The Bellco Fistula NeedlesFIE · Traditional 08/04/1980SE

Questions and answers

When was The Bravo New Parallel Flow Dialyzer cleared by the FDA?

The Bravo New Parallel Flow Dialyzer (K801633) received a 510(k) decision of Substantially Equivalent on December 18, 1980, 156 days after the submission was received.

What is the product code of K801633?

The FDA product code is FJG – Dialyzer, Parallel Flow, a Class II (moderate risk) device regulated under 21 CFR 876.5820.