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510(k) K895214

HEMOSTASIS VALVE by Applied Vascular Devices, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1989
Date Received
August 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
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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