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FDA 510(k)

GRAFT THROMBECTOMY INSTRUMENTS

K-Number: K942457 · 1995-02-07

ApplicantIntramed Laboratories, Inc.
Decision Date1995-02-07
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GRAFT THROMBECTOMY INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Intramed Laboratories, Inc.. It received FDA 510(k) clearance on 1995-02-07 under 510(k) number K942457. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAFT THROMBECTOMY INSTRUMENTS?

GRAFT THROMBECTOMY INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1995-02-07. The listed applicant is Intramed Laboratories, Inc.. The 510(k) number is K942457.

When did GRAFT THROMBECTOMY INSTRUMENTS receive FDA 510(k) clearance?

GRAFT THROMBECTOMY INSTRUMENTS received FDA 510(k) clearance on 1995-02-07, under 510(k) number K942457.

Who is the listed applicant for GRAFT THROMBECTOMY INSTRUMENTS?

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

What is the FDA product code for GRAFT THROMBECTOMY INSTRUMENTS?

The FDA product code for GRAFT THROMBECTOMY INSTRUMENTS is MCW.

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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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