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510(k) K910079

DISPOSABLE INTRODUCER SHEATH by Applied Vascular Devices, Inc. — Product Code KDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1991
Date Received
January 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • 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)
  • K902256 — IRRIGATION CATHETER 4, 6 AND 10 FRENCH (February 15, 1991)
  • K904379 — SURGICAL TROCAR AND CANNULA (December 21, 1990)

Other clearances for product code KDC

  • K943229 — DISPOSABLE SURGICAL SCISSORS AND FORCEPS (August 19, 1994)
  • K936226 — SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET (March 7, 1994)
  • K920153 — THERMUFF BAG (July 1, 1992)
  • K920263 — MANUAL SURGICAL INSTRUMENTS (May 6, 1992)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K914960 — INSTRUMENT ORGANIZER (February 28, 1992)
  • K912834 — SHUR-GRIP (July 26, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)
  • K900566 — RICHARD-ALLAN VESSEL LOOPS (May 3, 1990)