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)

FILTER, INTRAVENOUS W/AUTO AIR VENT

K-Number: K770589 · 1977-05-23

ApplicantJelco Laboratories
Decision Date1977-05-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FILTER, INTRAVENOUS W/AUTO AIR VENT is the device name listed in this FDA 510(k) record. The listed applicant is Jelco Laboratories. It received FDA 510(k) clearance on 1977-05-23 under 510(k) number K770589. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FILTER, INTRAVENOUS W/AUTO AIR VENT?

FILTER, INTRAVENOUS W/AUTO AIR VENT is a medical device that received FDA 510(k) clearance on 1977-05-23. The listed applicant is Jelco Laboratories. The 510(k) number is K770589.

When did FILTER, INTRAVENOUS W/AUTO AIR VENT receive FDA 510(k) clearance?

FILTER, INTRAVENOUS W/AUTO AIR VENT received FDA 510(k) clearance on 1977-05-23, under 510(k) number K770589.

Who is the listed applicant for FILTER, INTRAVENOUS W/AUTO AIR VENT?

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

What is the FDA product code for FILTER, INTRAVENOUS W/AUTO AIR VENT?

The FDA product code for FILTER, INTRAVENOUS W/AUTO AIR VENT is FPA.

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 Jelco Laboratories 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.

K791918JELCO WINGED INTRAVASCULAR CATHETERK791372JELCO & KVO CATHETER PLACEMENT UNITK790967CATHETER METAL HUB/RADIOPAQUEK790968CATHETER METAL HUB/NONRADIOPAQUEK790471JELCO* DISC FILTER-0.2 MICRONK790186PROTECTIVSTABILIZER

View all 26 devices →

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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.

↑