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FDA 510(k)

PERCUTANEOUS INTRODUCER SET

K-Number: K800462 · 1980-03-19

ApplicantMedical Components, Inc.
Decision Date1980-03-19
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS INTRODUCER SET 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 1980-03-19 under 510(k) number K800462. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCUTANEOUS INTRODUCER SET?

PERCUTANEOUS INTRODUCER SET is a medical device that received FDA 510(k) clearance on 1980-03-19. The listed applicant is Medical Components, Inc.. The 510(k) number is K800462.

When did PERCUTANEOUS INTRODUCER SET receive FDA 510(k) clearance?

PERCUTANEOUS INTRODUCER SET received FDA 510(k) clearance on 1980-03-19, under 510(k) number K800462.

Who is the listed applicant for PERCUTANEOUS INTRODUCER SET?

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 PERCUTANEOUS INTRODUCER SET?

The FDA product code for PERCUTANEOUS INTRODUCER SET is DRE.

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Other records listing Medical Components, Inc. as applicant

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Related Devices (Code: DRE)

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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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