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FDA 510(k)

BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET

K-Number: K851101 · 1985-04-12

ApplicantBionomy, Inc.
Decision Date1985-04-12
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET is the device name listed in this FDA 510(k) record. The listed applicant is Bionomy, Inc.. It received FDA 510(k) clearance on 1985-04-12 under 510(k) number K851101. 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 BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET?

BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET is a medical device that received FDA 510(k) clearance on 1985-04-12. The listed applicant is Bionomy, Inc.. The 510(k) number is K851101.

When did BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET receive FDA 510(k) clearance?

BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET received FDA 510(k) clearance on 1985-04-12, under 510(k) number K851101.

Who is the listed applicant for BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET?

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

What is the FDA product code for BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET?

The FDA product code for BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET is FOZ.

Related Clinical Trials

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.

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Other records listing Bionomy, 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.

K844094PRUITT IRRIGATION AND OCCLUSION CATHETERK832023EMBOLECTOMY CATHETERK812111PRUITT ARTERIAL OCCLUSION CHOLANG. CATHK811276OCCLUSION CATHETER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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