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510(k) K833059

SUCTION CATHETER TRAYS by Intermed, Inc. — Product Code GBZ

K833059 is an FDA 510(k) premarket notification submitted by Intermed, Inc. for the device "SUCTION CATHETER TRAYS". The FDA issued a decision of Substantially Equivalent on December 12, 1983. The device falls under product code GBZ (Catheter, Cholangiography), a Class I device regulated under 21 CFR 878.4200. Intermed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1983
Date Received
September 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cholangiography
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Intermed, Inc.

  • K900857 — NON STERILE PARENTERAL SUPPLY KIT (May 22, 1990)
  • K842166 — INTERMED, INS STERILE WATER/SALINE (February 12, 1985)
  • K833126 — DRESSING CHANGE TRAYS (January 27, 1984)
  • K833573 — CENTRAL VEIN CATH. TRAY CC-20-1420 (January 11, 1984)
  • K833574 — PERCUTANEOUS SHEATH INTRODUCER TRAYS (January 11, 1984)
  • K833139 — ACUTE HEMODIALYSIS TRAYS (December 22, 1983)
  • K821269 — TRACHEOSTOMY CARE TRAYS (May 27, 1982)
  • K791427 — CATHETERIZATION TRAYS FOLEY AND URETHRAL (September 7, 1979)
  • K791426 — PERITONEAL PAC (August 28, 1979)
  • K781748 — IRRIGATION TRAY (December 12, 1978)

Other clearances for product code GBZ

  • K973621 — PRE-VIEW CHOLANGIOGRAPHY CLAMP (December 17, 1997)
  • K944790 — FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (November 29, 1994)
  • K942450 — ENDOPATH (August 5, 1994)
  • K932228 — MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER (August 10, 1993)
  • K926217 — TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE (July 13, 1993)
  • K924212 — STRYKER ENDOSCOPY CHOLANGIOGRAM KIT (July 7, 1993)
  • K926143 — ANGIOLAPCATH CHOLANGIOGRAPHY KIT (July 7, 1993)
  • K925742 — CLARUS CHOLANGIOGRAM CATHETER KIT (June 1, 1993)
  • K924981 — OPERATIVE CHOLANGIOGRAM CATHETER (April 6, 1993)
  • K924480 — CHOLANGIOGRAPHY CLAMP (March 3, 1993)

FDA data resources