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)

AMER. BENTLEY HEMOFILTER HOLDER HFH-1

K-Number: K843504 · 1984-10-18

ApplicantAmerican Bentley
Decision Date1984-10-18
Product CodeFKI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMER. BENTLEY HEMOFILTER HOLDER HFH-1 is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1984-10-18 under 510(k) number K843504. The device is classified under product code FKI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMER. BENTLEY HEMOFILTER HOLDER HFH-1?

AMER. BENTLEY HEMOFILTER HOLDER HFH-1 is a medical device that received FDA 510(k) clearance on 1984-10-18. The listed applicant is American Bentley. The 510(k) number is K843504.

When did AMER. BENTLEY HEMOFILTER HOLDER HFH-1 receive FDA 510(k) clearance?

AMER. BENTLEY HEMOFILTER HOLDER HFH-1 received FDA 510(k) clearance on 1984-10-18, under 510(k) number K843504.

Who is the listed applicant for AMER. BENTLEY HEMOFILTER HOLDER HFH-1?

The FDA 510(k) record lists American Bentley as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMER. BENTLEY HEMOFILTER HOLDER HFH-1?

The FDA product code for AMER. BENTLEY HEMOFILTER HOLDER HFH-1 is FKI.

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 American Bentley 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.

K872896UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100K873923INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTERK870804CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100K872167CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500K872133OXYGENATOR MODEL NO. BENTLEY 5 PLUSK870911INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY

View all 59 devices →

Related Devices (Code: FKI)

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.

K811292PARALLEL PLATE DIALYZER HOLDERExtracorporeal Medical Specialities, Inc.K802075HOLLOW FIBER DIALYZER HOLDERRenal Devices, 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.

↑