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)

DOUBLE LUMEN E T ADAPTOR

K-Number: K862435 · 1986-10-22

ApplicantAcutronic Medical Systems AG
Decision Date1986-10-22
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DOUBLE LUMEN E T ADAPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Acutronic Medical Systems AG. It received FDA 510(k) clearance on 1986-10-22 under 510(k) number K862435. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOUBLE LUMEN E T ADAPTOR?

DOUBLE LUMEN E T ADAPTOR is a medical device that received FDA 510(k) clearance on 1986-10-22. The listed applicant is Acutronic Medical Systems AG. The 510(k) number is K862435.

When did DOUBLE LUMEN E T ADAPTOR receive FDA 510(k) clearance?

DOUBLE LUMEN E T ADAPTOR received FDA 510(k) clearance on 1986-10-22, under 510(k) number K862435.

Who is the listed applicant for DOUBLE LUMEN E T ADAPTOR?

The FDA 510(k) record lists Acutronic Medical Systems AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOUBLE LUMEN E T ADAPTOR?

The FDA product code for DOUBLE LUMEN E T ADAPTOR is BZA.

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 Acutronic Medical Systems AG 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.

K012691MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIESK012693MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIESK936009AMS 3000MK900745VS-200S JET VENTILATORK900744AMS 3000 PORTABLE JET VENTILATORK883865EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010

View all 12 devices →

Related Devices (Code: BZA)

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.

K083702TRACH-ASSISTMergenet MedicalK954383SURELOC CIRCUIT CONNECTORPolamedco, Inc.K954197DISPOSABLE FLEX TUBEEngstrom MedicalK953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONSUnicor, Inc.K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, 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.

↑