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FDA 510(k)

CentriMag Pre-connected Pack

K-Number: K222297 · 2022-12-01

ApplicantAbbott
Decision Date2022-12-01
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CentriMag Pre-connected Pack is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2022-12-01 under 510(k) number K222297. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CentriMag Pre-connected Pack?

CentriMag Pre-connected Pack is a medical device that received FDA 510(k) clearance on 2022-12-01. The listed applicant is Abbott. The 510(k) number is K222297.

When did CentriMag Pre-connected Pack receive FDA 510(k) clearance?

CentriMag Pre-connected Pack received FDA 510(k) clearance on 2022-12-01, under 510(k) number K222297.

Who is the listed applicant for CentriMag Pre-connected Pack?

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

What is the FDA product code for CentriMag Pre-connected Pack?

The FDA product code for CentriMag Pre-connected Pack is DTZ.

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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.

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