FDA 510(k)

CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE

K-Number: K963758 · 1998-02-20

Decision Date1998-02-20

Product CodeCAC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedical, Inc.. It received FDA 510(k) clearance on 1998-02-20 under 510(k) number K963758. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE?

CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE is a medical device that received FDA 510(k) clearance on 1998-02-20. The listed applicant is Sorin Biomedical, Inc.. The 510(k) number is K963758.

When did CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE receive FDA 510(k) clearance?

CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE received FDA 510(k) clearance on 1998-02-20, under 510(k) number K963758.

Who is the listed applicant for CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE?

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

What is the FDA product code for CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE?

The FDA product code for CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE is CAC.

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Other records listing Sorin Biomedical, Inc. as applicant

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Related Devices (Code: CAC)

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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.