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FDA 510(k)

ANETHESIA BREATHING CIRCUIT

K-Number: K895357 · 1989-10-19

ApplicantF.L.W. Plastics, Inc.
Decision Date1989-10-19
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ANETHESIA BREATHING CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is F.L.W. Plastics, Inc.. It received FDA 510(k) clearance on 1989-10-19 under 510(k) number K895357. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANETHESIA BREATHING CIRCUIT?

ANETHESIA BREATHING CIRCUIT is a medical device that received FDA 510(k) clearance on 1989-10-19. The listed applicant is F.L.W. Plastics, Inc.. The 510(k) number is K895357.

When did ANETHESIA BREATHING CIRCUIT receive FDA 510(k) clearance?

ANETHESIA BREATHING CIRCUIT received FDA 510(k) clearance on 1989-10-19, under 510(k) number K895357.

Who is the listed applicant for ANETHESIA BREATHING CIRCUIT?

The FDA 510(k) record lists F.L.W. Plastics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANETHESIA BREATHING CIRCUIT?

The FDA product code for ANETHESIA BREATHING CIRCUIT is CAI.

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 F.L.W. Plastics, 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.

K900291MASS SPECTROMETRY MONITORING LINES AND CONNECTORSK895233BACTERIAL AND VIRAL FILTERK895169MANUAL DISPOSABLE PULMONARY RESUSCITATOR

Related Devices (Code: CAI)

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.

K954480CONDENSATE COLLECTION KITNova-VentrxK953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.K952018PRIMA COAXIAL CIRCUITSPrima, Inc.K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, Inc.

Official Source

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

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