FDA 510(k)

JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100

K-Number: K082664 · 2008-10-06

ApplicantPathway Medical Technologies, Inc.

Decision Date2008-10-06

Product CodeMCW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 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 2008-10-06 under 510(k) number K082664. 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 JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100?

JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 is a medical device that received FDA 510(k) clearance on 2008-10-06. The listed applicant is Pathway Medical Technologies, Inc.. The 510(k) number is K082664.

When did JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 receive FDA 510(k) clearance?

JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 received FDA 510(k) clearance on 2008-10-06, under 510(k) number K082664.

Who is the listed applicant for JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100?

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 JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100?

The FDA product code for JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 is MCW.

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Other records listing Pathway Medical Technologies, Inc. as applicant

K120242JETSTREAM NAVITUS L SYSTEM K111229JETSTREAM G3 (R) SF 1.6 SYSTEM K110626JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM K101334JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON K101221JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 K100462JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100

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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.