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FDA 510(k)

RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI

K-Number: K840336 · 1984-02-17

ApplicantArrow Intl., Inc.
Decision Date1984-02-17
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1984-02-17 under 510(k) number K840336. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI?

RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI is a medical device that received FDA 510(k) clearance on 1984-02-17. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K840336.

When did RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI receive FDA 510(k) clearance?

RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI received FDA 510(k) clearance on 1984-02-17, under 510(k) number K840336.

Who is the listed applicant for RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI?

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

What is the FDA product code for RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI?

The FDA product code for RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI is DQY.

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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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