FDA 510(k)

MEDRAD MANUAL SYRINGE LOADER

K-Number: K031483 · 2003-08-01

Decision Date2003-08-01

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDRAD MANUAL SYRINGE LOADER is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 2003-08-01 under 510(k) number K031483. 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 MANUAL SYRINGE LOADER?

MEDRAD MANUAL SYRINGE LOADER is a medical device that received FDA 510(k) clearance on 2003-08-01. The listed applicant is Medrad, Inc.. The 510(k) number is K031483.

When did MEDRAD MANUAL SYRINGE LOADER receive FDA 510(k) clearance?

MEDRAD MANUAL SYRINGE LOADER received FDA 510(k) clearance on 2003-08-01, under 510(k) number K031483.

Who is the listed applicant for MEDRAD MANUAL SYRINGE LOADER?

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 MANUAL SYRINGE LOADER?

The FDA product code for MEDRAD MANUAL SYRINGE LOADER is DXT.

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Other records listing Medrad, Inc. as applicant

K130381ANGIOJET ULTRA POWER PULSE KIT K130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM K122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM K113363ANGIOJET SOLENT DISTA THROMBECTOMY SET K113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE K113428ANGIOJET ULTRA DVX THROMBECTOMY SET

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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.