FDA 510(k)

JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300

K-Number: K083489 · 2009-01-23

ApplicantPathway Medical Technologies, Inc.

Decision Date2009-01-23

Product CodeMCW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 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 2009-01-23 under 510(k) number K083489. 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 PC ATHERECTOMY SYSTEM, MODEL OV10300?

JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 is a medical device that received FDA 510(k) clearance on 2009-01-23. The listed applicant is Pathway Medical Technologies, Inc.. The 510(k) number is K083489.

When did JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 receive FDA 510(k) clearance?

JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 received FDA 510(k) clearance on 2009-01-23, under 510(k) number K083489.

Who is the listed applicant for JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300?

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 PC ATHERECTOMY SYSTEM, MODEL OV10300?

The FDA product code for JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 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.