FDA 510(k)

JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM

K-Number: K110626 · 2011-04-20

ApplicantPathway Medical Technologies, Inc.

Decision Date2011-04-20

Product CodeMCW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L 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 2011-04-20 under 510(k) number K110626. 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 NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM?

JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM is a medical device that received FDA 510(k) clearance on 2011-04-20. The listed applicant is Pathway Medical Technologies, Inc.. The 510(k) number is K110626.

When did JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM receive FDA 510(k) clearance?

JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM received FDA 510(k) clearance on 2011-04-20, under 510(k) number K110626.

Who is the listed applicant for JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L 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 JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM?

The FDA product code for JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM 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 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 K093918JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)

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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.