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FDA 510(k)

MEDRAD PATHFINDER-E ROADMAPPING SYSTEM

K-Number: K922274 · 1992-10-09

ApplicantMedrad, Inc.
Decision Date1992-10-09
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDRAD PATHFINDER-E ROADMAPPING 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 1992-10-09 under 510(k) number K922274. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD PATHFINDER-E ROADMAPPING SYSTEM?

MEDRAD PATHFINDER-E ROADMAPPING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-10-09. The listed applicant is Medrad, Inc.. The 510(k) number is K922274.

When did MEDRAD PATHFINDER-E ROADMAPPING SYSTEM receive FDA 510(k) clearance?

MEDRAD PATHFINDER-E ROADMAPPING SYSTEM received FDA 510(k) clearance on 1992-10-09, under 510(k) number K922274.

Who is the listed applicant for MEDRAD PATHFINDER-E ROADMAPPING 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 PATHFINDER-E ROADMAPPING SYSTEM?

The FDA product code for MEDRAD PATHFINDER-E ROADMAPPING SYSTEM is JAA.

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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: JAA)

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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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