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FDA 510(k)

EPISTAXIS BALLOON CATHETER WITH PACKING

K-Number: K945554 · 1995-02-17

ApplicantUltracell Medical Technologies, Inc.
Decision Date1995-02-17
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EPISTAXIS BALLOON CATHETER WITH PACKING is the device name listed in this FDA 510(k) record. The listed applicant is Ultracell Medical Technologies, Inc.. It received FDA 510(k) clearance on 1995-02-17 under 510(k) number K945554. 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 BALLOON CATHETER WITH PACKING?

EPISTAXIS BALLOON CATHETER WITH PACKING is a medical device that received FDA 510(k) clearance on 1995-02-17. The listed applicant is Ultracell Medical Technologies, Inc.. The 510(k) number is K945554.

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

EPISTAXIS BALLOON CATHETER WITH PACKING received FDA 510(k) clearance on 1995-02-17, under 510(k) number K945554.

Who is the listed applicant for EPISTAXIS BALLOON CATHETER WITH PACKING?

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

What is the FDA product code for EPISTAXIS BALLOON CATHETER WITH PACKING?

The FDA product code for EPISTAXIS BALLOON CATHETER WITH PACKING is EMX.

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Other records listing Ultracell Medical Technologies, 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.

K012196ULTRACELL ABSORBENT STICKK972633ULTRACELL SUCTION SPONGEK972634ULTRACELL SUCTION SPONGEK973083ULTRACELL NEURO SPONGESK973558VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)K973085ULTRACELL PACKING WITH SLEEVE

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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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