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FDA 510(k)

BIOSENSORS CENTRAL VENOUS CATHETER KITS

K-Number: K002786 · 2000-11-17

ApplicantSunscope Intl., Inc.
Decision Date2000-11-17
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOSENSORS CENTRAL VENOUS CATHETER KITS is the device name listed in this FDA 510(k) record. The listed applicant is Sunscope Intl., Inc.. It received FDA 510(k) clearance on 2000-11-17 under 510(k) number K002786. 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 BIOSENSORS CENTRAL VENOUS CATHETER KITS?

BIOSENSORS CENTRAL VENOUS CATHETER KITS is a medical device that received FDA 510(k) clearance on 2000-11-17. The listed applicant is Sunscope Intl., Inc.. The 510(k) number is K002786.

When did BIOSENSORS CENTRAL VENOUS CATHETER KITS receive FDA 510(k) clearance?

BIOSENSORS CENTRAL VENOUS CATHETER KITS received FDA 510(k) clearance on 2000-11-17, under 510(k) number K002786.

Who is the listed applicant for BIOSENSORS CENTRAL VENOUS CATHETER KITS?

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

What is the FDA product code for BIOSENSORS CENTRAL VENOUS CATHETER KITS?

The FDA product code for BIOSENSORS CENTRAL VENOUS CATHETER KITS is FOZ.

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Other records listing Sunscope Intl., 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.

K983372BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BPK973477BIOSENSORS EMBOLECTOMY CATHETERK981747BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXXK981745BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXXK911710HEPARIN COATED THERMODILUTION CATH & ACCESSORIESK912172SAFEWEDGE(TM) RELIEF VALVE DEVICE

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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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