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FDA 510(k)

HEMO-CATH 10F, HEMO-CATH 12.5F

K-Number: K113487 · 2012-03-09

ApplicantMedical Components, Inc.
Decision Date2012-03-09
Product CodeMSD
Advisory CommitteeGU
DecisionUnknown

Device Summary

HEMO-CATH 10F, HEMO-CATH 12.5F is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 2012-03-09 under 510(k) number K113487. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the HEMO-CATH 10F, HEMO-CATH 12.5F?

HEMO-CATH 10F, HEMO-CATH 12.5F is a medical device that received FDA 510(k) clearance on 2012-03-09. The listed applicant is Medical Components, Inc.. The 510(k) number is K113487.

When did HEMO-CATH 10F, HEMO-CATH 12.5F receive FDA 510(k) clearance?

HEMO-CATH 10F, HEMO-CATH 12.5F received FDA 510(k) clearance on 2012-03-09, under 510(k) number K113487.

Who is the listed applicant for HEMO-CATH 10F, HEMO-CATH 12.5F?

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

What is the FDA product code for HEMO-CATH 10F, HEMO-CATH 12.5F?

The FDA product code for HEMO-CATH 10F, HEMO-CATH 12.5F is MSD.

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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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