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FDA 510(k)

ANTI-THROMBOGENIC COATING FOR CATHETERS

K-Number: K895191 · 1989-11-24

ApplicantBurron Medical, Inc.
Decision Date1989-11-24
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ANTI-THROMBOGENIC COATING FOR CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical, Inc.. It received FDA 510(k) clearance on 1989-11-24 under 510(k) number K895191. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-THROMBOGENIC COATING FOR CATHETERS?

ANTI-THROMBOGENIC COATING FOR CATHETERS is a medical device that received FDA 510(k) clearance on 1989-11-24. The listed applicant is Burron Medical, Inc.. The 510(k) number is K895191.

When did ANTI-THROMBOGENIC COATING FOR CATHETERS receive FDA 510(k) clearance?

ANTI-THROMBOGENIC COATING FOR CATHETERS received FDA 510(k) clearance on 1989-11-24, under 510(k) number K895191.

Who is the listed applicant for ANTI-THROMBOGENIC COATING FOR CATHETERS?

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

What is the FDA product code for ANTI-THROMBOGENIC COATING FOR CATHETERS?

The FDA product code for ANTI-THROMBOGENIC COATING FOR CATHETERS is FOZ.

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Other records listing Burron Medical, 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.

K902401CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEMK896422BURRON AMBULATORY DRUG DELIVERY SYSTEMK884235COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KITK895192SPINOCAN(R) CONTINUOUS SPINAL TRAYK884183BURRON TEFLON-COATED GUIDEWIREK882106PERFUSOR M SYRINGE PUMP

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Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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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