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)

PRIMA MAPLESON D CIRCUIT

K-Number: K952017 · 1995-05-22

ApplicantPrima, Inc.
Decision Date1995-05-22
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRIMA MAPLESON D CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Prima, Inc.. It received FDA 510(k) clearance on 1995-05-22 under 510(k) number K952017. 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 PRIMA MAPLESON D CIRCUIT?

PRIMA MAPLESON D CIRCUIT is a medical device that received FDA 510(k) clearance on 1995-05-22. The listed applicant is Prima, Inc.. The 510(k) number is K952017.

When did PRIMA MAPLESON D CIRCUIT receive FDA 510(k) clearance?

PRIMA MAPLESON D CIRCUIT received FDA 510(k) clearance on 1995-05-22, under 510(k) number K952017.

Who is the listed applicant for PRIMA MAPLESON D CIRCUIT?

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

What is the FDA product code for PRIMA MAPLESON D CIRCUIT?

The FDA product code for PRIMA MAPLESON D 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 Prima, 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.

K952011PRIMA BREATHING BAGSK952010PRIMA VENTILATOR HOSESK952022PRIMA VOLUMN VENTILATORSSK952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSK952018PRIMA COAXIAL CIRCUITSK952012PRIMA CUSTOM ANESTESIA CIRCUIT

View all 19 devices →

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

View on FDA Database →

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

↑