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510(k) K130637

JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM by Medrad, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2013
Date Received
March 11, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peripheral, Atherectomy
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

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  • K113428 — ANGIOJET ULTRA DVX THROMBECTOMY SET (December 2, 2011)
  • K112086 — MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 AR (October 14, 2011)
  • K111182 — ANGIOJET SOLENT OMNI THROMBECTOMY SET (May 24, 2011)
  • K100798 — MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRAT (June 23, 2010)
  • K082905 — MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC (January 12, 2009)

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