Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

THE BRAVO NEW PARALLEL FLOW DIALYZER

K-Number: K801633 · 1980-12-18

ApplicantBellco Artifidial Organ Spec., Inc.
Decision Date1980-12-18
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE BRAVO NEW PARALLEL FLOW DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Bellco Artifidial Organ Spec., Inc.. It received FDA 510(k) clearance on 1980-12-18 under 510(k) number K801633. The device is classified under product code FJG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE BRAVO NEW PARALLEL FLOW DIALYZER?

THE BRAVO NEW PARALLEL FLOW DIALYZER is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is Bellco Artifidial Organ Spec., Inc.. The 510(k) number is K801633.

When did THE BRAVO NEW PARALLEL FLOW DIALYZER receive FDA 510(k) clearance?

THE BRAVO NEW PARALLEL FLOW DIALYZER received FDA 510(k) clearance on 1980-12-18, under 510(k) number K801633.

Who is the listed applicant for THE BRAVO NEW PARALLEL FLOW DIALYZER?

The FDA 510(k) record lists Bellco Artifidial Organ Spec., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE BRAVO NEW PARALLEL FLOW DIALYZER?

The FDA product code for THE BRAVO NEW PARALLEL FLOW DIALYZER is FJG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bellco Artifidial Organ Spec., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K801634THE VITA 2 DISPOSABLE DIALYZERK801632THE BELLCO FISTULA NEEDLES

Related Devices (Code: FJG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.K933680GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.K920693DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9National Medical Care, Medical Products Div., Inc.K915504GAMBRO LUNDIA ALPHA HEMODIALYZERSC.G.H. Medical, Inc.K901368HEMOSPAL KITS A1, A2D, AO, & A1DGambro-Hospal, Inc.K902203TENCKHOFF PERITONEAL DIALYSIS KITAkcess Medical Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑