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FDA 510(k)

ABC IN-LINE BLOOD SAMPLING KIT

K-Number: K955663 · 1997-03-17

ApplicantUtah Medical Products, Inc.
Decision Date1997-03-17
Product CodeCBT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ABC IN-LINE BLOOD SAMPLING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Utah Medical Products, Inc.. It received FDA 510(k) clearance on 1997-03-17 under 510(k) number K955663. The device is classified under product code CBT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABC IN-LINE BLOOD SAMPLING KIT?

ABC IN-LINE BLOOD SAMPLING KIT is a medical device that received FDA 510(k) clearance on 1997-03-17. The listed applicant is Utah Medical Products, Inc.. The 510(k) number is K955663.

When did ABC IN-LINE BLOOD SAMPLING KIT receive FDA 510(k) clearance?

ABC IN-LINE BLOOD SAMPLING KIT received FDA 510(k) clearance on 1997-03-17, under 510(k) number K955663.

Who is the listed applicant for ABC IN-LINE BLOOD SAMPLING KIT?

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

What is the FDA product code for ABC IN-LINE BLOOD SAMPLING KIT?

The FDA product code for ABC IN-LINE BLOOD SAMPLING KIT is CBT.

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Other records listing Utah 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.

K123310FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)K101535BT-CATHK063611SALINE/ CONTRAST MEDIA INFUSION CATHETERK001874PERIPHERALLY INSERTED CENTRAL CATHETERK000974FOWLER ENDOCURETTE, MODEL CUR-XXXK965245TBD

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Related Devices (Code: CBT)

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.

K071269HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K070340SECURE ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K954015ABG POINT LOK NEEDLE PROTECTION DEVICEDevon Industries, Inc.K954035ACTI-FLEX ARTERIAL EXTENSION SETR-Group Intl.K950098NEEDLE SAFETY COVERHammer-Plane, Inc.K945719ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEMSherwood Medical Co.

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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