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FDA 510(k)

NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET

K-Number: K932391 · 1994-01-27

ApplicantNavarre Biomedical , Ltd.
Decision Date1994-01-27
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Navarre Biomedical , Ltd.. It received FDA 510(k) clearance on 1994-01-27 under 510(k) number K932391. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET?

NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET is a medical device that received FDA 510(k) clearance on 1994-01-27. The listed applicant is Navarre Biomedical , Ltd.. The 510(k) number is K932391.

When did NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET receive FDA 510(k) clearance?

NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET received FDA 510(k) clearance on 1994-01-27, under 510(k) number K932391.

Who is the listed applicant for NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET?

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

What is the FDA product code for NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET?

The FDA product code for NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET is GBX.

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Other records listing Navarre Biomedical , Ltd. 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.

K955110NAVARRE PERCUTANEOUS BILIARY DRAINAGEK955505OPTI-DRAIN MULTI-USE DRAINAGE CATHETERK945909NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETERK951907NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETERK951475NAVARRE UNIVERSAL DRAINAGE CATHETERK943663NAVARRE 600 ML DRAINAGE BAG

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Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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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