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FDA 510(k)

MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM

K-Number: K021988 · 2002-08-29

ApplicantMedrad, Inc.
Decision Date2002-08-29
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 2002-08-29 under 510(k) number K021988. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM?

MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-08-29. The listed applicant is Medrad, Inc.. The 510(k) number is K021988.

When did MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM receive FDA 510(k) clearance?

MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM received FDA 510(k) clearance on 2002-08-29, under 510(k) number K021988.

Who is the listed applicant for MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM?

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 CONTINUUM MR COMPATIBLE INFUSION SYSTEM?

The FDA product code for MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM is FRN.

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Other records listing Medrad, Inc. as applicant

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K130381ANGIOJET ULTRA POWER PULSE KITK130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEMK122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEMK113363ANGIOJET SOLENT DISTA THROMBECTOMY SETK113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEK113428ANGIOJET ULTRA DVX THROMBECTOMY SET

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Related Devices (Code: FRN)

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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.

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