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FDA 510(k)

BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP

K-Number: K983372 · 1999-02-05

ApplicantSunscope Intl., Inc.
Decision Date1999-02-05
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP 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 1999-02-05 under 510(k) number K983372. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP?

BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP is a medical device that received FDA 510(k) clearance on 1999-02-05. The listed applicant is Sunscope Intl., Inc.. The 510(k) number is K983372.

When did BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP receive FDA 510(k) clearance?

BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP received FDA 510(k) clearance on 1999-02-05, under 510(k) number K983372.

Who is the listed applicant for BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP?

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 BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP?

The FDA product code for BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP is DRS.

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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.

K002786BIOSENSORS CENTRAL VENOUS CATHETER KITSK973477BIOSENSORS 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: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation

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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