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FDA 510(k)

TAXOL ADMINISTRATION SET

K-Number: K003513 · 2001-01-11

ApplicantIcu Medical, Inc.
Decision Date2001-01-11
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TAXOL ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2001-01-11 under 510(k) number K003513. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAXOL ADMINISTRATION SET?

TAXOL ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 2001-01-11. The listed applicant is Icu Medical, Inc.. The 510(k) number is K003513.

When did TAXOL ADMINISTRATION SET receive FDA 510(k) clearance?

TAXOL ADMINISTRATION SET received FDA 510(k) clearance on 2001-01-11, under 510(k) number K003513.

Who is the listed applicant for TAXOL ADMINISTRATION SET?

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

What is the FDA product code for TAXOL ADMINISTRATION SET?

The FDA product code for TAXOL ADMINISTRATION SET is FPA.

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Related Devices (Code: FPA)

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.

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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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