FDA 510(k)

ANGIOJECT

K-Number: K860842 · 1986-04-23

Decision Date1986-04-23

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ANGIOJECT is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1986-04-23 under 510(k) number K860842. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIOJECT?

ANGIOJECT is a medical device that received FDA 510(k) clearance on 1986-04-23. The listed applicant is Target Therapeutics. The 510(k) number is K860842.

When did ANGIOJECT receive FDA 510(k) clearance?

ANGIOJECT received FDA 510(k) clearance on 1986-04-23, under 510(k) number K860842.

Who is the listed applicant for ANGIOJECT?

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

What is the FDA product code for ANGIOJECT?

The FDA product code for ANGIOJECT is DXT.

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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.