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FDA 510(k)

EPISTAXIS NASAL BALLOON CATHETER

K-Number: K921199 · 1992-07-08

ApplicantSmith & Nephew Richards, Inc.
Decision Date1992-07-08
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EPISTAXIS NASAL BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1992-07-08 under 510(k) number K921199. The device is classified under product code EMX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPISTAXIS NASAL BALLOON CATHETER?

EPISTAXIS NASAL BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1992-07-08. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K921199.

When did EPISTAXIS NASAL BALLOON CATHETER receive FDA 510(k) clearance?

EPISTAXIS NASAL BALLOON CATHETER received FDA 510(k) clearance on 1992-07-08, under 510(k) number K921199.

Who is the listed applicant for EPISTAXIS NASAL BALLOON CATHETER?

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

What is the FDA product code for EPISTAXIS NASAL BALLOON CATHETER?

The FDA product code for EPISTAXIS NASAL BALLOON CATHETER is EMX.

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Other records listing Smith & Nephew Richards, 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.

K965224EMPOWER ANTERIOR DIRECT SCREWSK963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONK960444FINN ROD TO ROD CONNECTORK964163TRIMAX NAIL SYSTEMK962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTK963486REVISION HIP SYSTEM

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Related Devices (Code: EMX)

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.

K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLCK041446NASALCEASELes Laboratorires Brothier, S.A.K000108RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100Bhk HoldingK993362HYLASINEBiomatrix, Inc.K983276HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLCK982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, 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.

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