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510(k) K081454

GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE by Possis Medical, Inc. — Product Code MJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2008
Date Received
May 23, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular Occluding, Temporary
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

Other clearances by Possis Medical, Inc.

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  • K091593 — ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS (June 22, 2009)
  • K090253 — ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR T (April 8, 2009)
  • K082382 — ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 (December 12, 2008)
  • K081989 — MODIFICATION TO FETCH ASPIRATION CATHETER (September 26, 2008)
  • K080806 — ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 (April 4, 2008)
  • K073441 — ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 (January 24, 2008)
  • K072769 — ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY S (November 14, 2007)
  • K072269 — ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 (September 8, 2007)
  • K071336 — ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 (August 24, 2007)

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  • K214060 — LANDMARK REBOA Catheter (September 19, 2022)
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  • K212324 — RenovoCath (August 23, 2021)
  • K210602 — AortaSTAT Occlusion Device (July 9, 2021)
  • K210358 — Neurescue device (May 21, 2021)
  • K201652 — COBRA-OS Kit (February 22, 2021)
  • K203540 — Bridge Occlusion Balloon (December 23, 2020)