FDA 510(k)

MEDRAD QWIK-FIT SYRINGE

K-Number: K013815 · 2001-12-13

Decision Date2001-12-13

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDRAD QWIK-FIT SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 2001-12-13 under 510(k) number K013815. 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 MEDRAD QWIK-FIT SYRINGE?

MEDRAD QWIK-FIT SYRINGE is a medical device that received FDA 510(k) clearance on 2001-12-13. The listed applicant is Medrad, Inc.. The 510(k) number is K013815.

When did MEDRAD QWIK-FIT SYRINGE receive FDA 510(k) clearance?

MEDRAD QWIK-FIT SYRINGE received FDA 510(k) clearance on 2001-12-13, under 510(k) number K013815.

Who is the listed applicant for MEDRAD QWIK-FIT SYRINGE?

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

What is the FDA product code for MEDRAD QWIK-FIT SYRINGE?

The FDA product code for MEDRAD QWIK-FIT SYRINGE is DXT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.