FDA 510(k)

RADIOPAQUE SPHERICAL EMBOLI (RSE)

K-Number: K871047 · 1987-05-22

ApplicantInterventional Therapeutics Corp.

Decision Date1987-05-22

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

RADIOPAQUE SPHERICAL EMBOLI (RSE) is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Therapeutics Corp.. It received FDA 510(k) clearance on 1987-05-22 under 510(k) number K871047. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOPAQUE SPHERICAL EMBOLI (RSE)?

RADIOPAQUE SPHERICAL EMBOLI (RSE) is a medical device that received FDA 510(k) clearance on 1987-05-22. The listed applicant is Interventional Therapeutics Corp.. The 510(k) number is K871047.

When did RADIOPAQUE SPHERICAL EMBOLI (RSE) receive FDA 510(k) clearance?

RADIOPAQUE SPHERICAL EMBOLI (RSE) received FDA 510(k) clearance on 1987-05-22, under 510(k) number K871047.

Who is the listed applicant for RADIOPAQUE SPHERICAL EMBOLI (RSE)?

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

What is the FDA product code for RADIOPAQUE SPHERICAL EMBOLI (RSE)?

The FDA product code for RADIOPAQUE SPHERICAL EMBOLI (RSE) is HCG.

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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.