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FDA 510(k)

INTRAFLON, INTRAFLUX, INTRAVALVE

K-Number: K813144 · 1981-11-27

ApplicantExco, Inc.
Decision Date1981-11-27
Product CodeDQR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRAFLON, INTRAFLUX, INTRAVALVE is the device name listed in this FDA 510(k) record. The listed applicant is Exco, Inc.. It received FDA 510(k) clearance on 1981-11-27 under 510(k) number K813144. The device is classified under product code DQR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAFLON, INTRAFLUX, INTRAVALVE?

INTRAFLON, INTRAFLUX, INTRAVALVE is a medical device that received FDA 510(k) clearance on 1981-11-27. The listed applicant is Exco, Inc.. The 510(k) number is K813144.

When did INTRAFLON, INTRAFLUX, INTRAVALVE receive FDA 510(k) clearance?

INTRAFLON, INTRAFLUX, INTRAVALVE received FDA 510(k) clearance on 1981-11-27, under 510(k) number K813144.

Who is the listed applicant for INTRAFLON, INTRAFLUX, INTRAVALVE?

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

What is the FDA product code for INTRAFLON, INTRAFLUX, INTRAVALVE?

The FDA product code for INTRAFLON, INTRAFLUX, INTRAVALVE is DQR.

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Related Devices (Code: DQR)

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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