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FDA 510(k)

KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501

K-Number: K032827 · 2003-12-08

ApplicantTyco Healthcare
Decision Date2003-12-08
Product CodeKSR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Healthcare. It received FDA 510(k) clearance on 2003-12-08 under 510(k) number K032827. The device is classified under product code KSR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501?

KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 is a medical device that received FDA 510(k) clearance on 2003-12-08. The listed applicant is Tyco Healthcare. The 510(k) number is K032827.

When did KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 receive FDA 510(k) clearance?

KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 received FDA 510(k) clearance on 2003-12-08, under 510(k) number K032827.

Who is the listed applicant for KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501?

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

What is the FDA product code for KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501?

The FDA product code for KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 is KSR.

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Related Devices (Code: KSR)

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.

K020753DEROYAL SURGICAL, UMBILICUPDeroyalK810897ALPHA PLASTIC PLASMA BOTTLEAlpha Therapeutic Corp.K810500BLOOD FREEZING BAGDelmed, Inc.K811523PLASMA FLEXTerumo America, Inc.K811449HAEMONETICS 1000ML COMPONENT BAGHaemonetics Corp.K810711HAEMONETICS 600 ML. COMPONENT BAGHaemonetics Corp.

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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