FDA 510(k)

INJECTOR HANDLE WITH SYRINGE

K-Number: K880987 · 1988-05-13

Decision Date1988-05-13

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INJECTOR HANDLE WITH SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Vascular Devices, Inc.. It received FDA 510(k) clearance on 1988-05-13 under 510(k) number K880987. 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 INJECTOR HANDLE WITH SYRINGE?

INJECTOR HANDLE WITH SYRINGE is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Applied Vascular Devices, Inc.. The 510(k) number is K880987.

When did INJECTOR HANDLE WITH SYRINGE receive FDA 510(k) clearance?

INJECTOR HANDLE WITH SYRINGE received FDA 510(k) clearance on 1988-05-13, under 510(k) number K880987.

Who is the listed applicant for INJECTOR HANDLE WITH SYRINGE?

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

What is the FDA product code for INJECTOR HANDLE WITH SYRINGE?

The FDA product code for INJECTOR HANDLE WITH SYRINGE 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.