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510(k) K901627

ARTERIAL EMBOLECTOMY CATHETER by Applied Vascular Devices, Inc. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1990
Date Received
April 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

Other clearances by Applied Vascular Devices, Inc.

  • K911730 — SURGICAL OBTURATOR WITH SEAL (December 23, 1991)
  • K911589 — DISPOSABLE SURGICAL TROCAR WITH SEAL (July 5, 1991)
  • K910339 — AVD INTIMAX OCCLUSION CATHETER (May 29, 1991)
  • K910372 — INTIMAX THROMBECTOMY CATHETER (April 26, 1991)
  • K911181 — INTIMAX(TM) IRRIGATION CATHETER (April 18, 1991)
  • K910493 — AVD INTIMAX CHOLANGIOGRAPHY CATHETER (March 28, 1991)
  • K903848 — DIAGNOSTIC INTRASCULAR CATHETER (March 25, 1991)
  • K905738 — OPERATIVE CHOLANGIOGRAPHIC CATHETER (March 21, 1991)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K902256 — IRRIGATION CATHETER 4, 6 AND 10 FRENCH (February 15, 1991)

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