FDA 510(k)

POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002

K-Number: K993564 · 2000-04-28

Decision Date2000-04-28

Product CodeMCW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 is the device name listed in this FDA 510(k) record. The listed applicant is Possis Medical, Inc.. It received FDA 510(k) clearance on 2000-04-28 under 510(k) number K993564. 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 POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002?

POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 is a medical device that received FDA 510(k) clearance on 2000-04-28. The listed applicant is Possis Medical, Inc.. The 510(k) number is K993564.

When did POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 receive FDA 510(k) clearance?

POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 received FDA 510(k) clearance on 2000-04-28, under 510(k) number K993564.

Who is the listed applicant for POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002?

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

What is the FDA product code for POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002?

The FDA product code for POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 is MCW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.