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FDA 510(k)

CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE

K-Number: K870403 · 1987-05-01

ApplicantBurron Medical Products, Inc.
Decision Date1987-05-01
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical Products, Inc.. It received FDA 510(k) clearance on 1987-05-01 under 510(k) number K870403. 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 CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE?

CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE is a medical device that received FDA 510(k) clearance on 1987-05-01. The listed applicant is Burron Medical Products, Inc.. The 510(k) number is K870403.

When did CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE receive FDA 510(k) clearance?

CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE received FDA 510(k) clearance on 1987-05-01, under 510(k) number K870403.

Who is the listed applicant for CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE?

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

What is the FDA product code for CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE?

The FDA product code for CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE is FOZ.

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Other records listing Burron Medical Products, 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.

K862412INTESTOPLANTK861479CAVAFIX, CENTRAL VENOUS CATHETER KITK860126STIMUPLEX, NERVE STIMULATORK851293IMPLANTOFIXK841428JEJUNOSTOMY SET FOR TUBE FEEDINGK834383DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT

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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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