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FDA 510(k)

PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY

K-Number: K812338 · 1981-09-23

ApplicantTerumo Medical Corp.
Decision Date1981-09-23
Product CodeCBT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K812338. 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 PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY?

PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Terumo Medical Corp.. The 510(k) number is K812338.

When did PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY receive FDA 510(k) clearance?

PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812338.

Who is the listed applicant for PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY?

The FDA 510(k) record lists Terumo Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY?

The FDA product code for PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY is CBT.

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Other records listing Terumo Medical Corp. as applicant

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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.K955663ABC IN-LINE BLOOD SAMPLING KITUtah Medical Products, Inc.K954015ABG POINT LOK NEEDLE PROTECTION DEVICEDevon Industries, Inc.K954035ACTI-FLEX ARTERIAL EXTENSION SETR-Group Intl.K950098NEEDLE SAFETY COVERHammer-Plane, 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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