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FDA 510(k)

MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM

K-Number: K082186 · 2008-08-29

ApplicantPathway Medical Technologies, Inc.
Decision Date2008-08-29
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pathway Medical Technologies, Inc.. It received FDA 510(k) clearance on 2008-08-29 under 510(k) number K082186. 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 MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM?

MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-29. The listed applicant is Pathway Medical Technologies, Inc.. The 510(k) number is K082186.

When did MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM received FDA 510(k) clearance on 2008-08-29, under 510(k) number K082186.

Who is the listed applicant for MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM?

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

What is the FDA product code for MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM?

The FDA product code for MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM is MCW.

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Other records listing Pathway Medical Technologies, Inc. as applicant

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Related Devices (Code: 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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