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FDA 510(k)

MEDRAD COUNTERPOISE SYSTEM

K-Number: K944983 · 1994-11-29

ApplicantMedrad, Inc.
Decision Date1994-11-29
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDRAD COUNTERPOISE 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 1994-11-29 under 510(k) number K944983. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD COUNTERPOISE SYSTEM?

MEDRAD COUNTERPOISE SYSTEM is a medical device that received FDA 510(k) clearance on 1994-11-29. The listed applicant is Medrad, Inc.. The 510(k) number is K944983.

When did MEDRAD COUNTERPOISE SYSTEM receive FDA 510(k) clearance?

MEDRAD COUNTERPOISE SYSTEM received FDA 510(k) clearance on 1994-11-29, under 510(k) number K944983.

Who is the listed applicant for MEDRAD COUNTERPOISE 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 COUNTERPOISE SYSTEM?

The FDA product code for MEDRAD COUNTERPOISE SYSTEM is JAK.

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Other records listing Medrad, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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