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510(k) K870420

PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY by North Coast Medi-Tek — Product Code GBZ

K870420 is an FDA 510(k) premarket notification submitted by North Coast Medi-Tek for the device "PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY". The FDA issued a decision of Substantially Equivalent (with conditions) on April 14, 1987. The device falls under product code GBZ (Catheter, Cholangiography), a Class I device regulated under 21 CFR 878.4200. North Coast Medi-Tek has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
April 14, 1987
Date Received
February 3, 1987
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 North Coast Medi-Tek

  • K870419 — IVR-SP CUSTOM ANGIOGRAPHY TRAY (May 11, 1987)
  • K870416 — LP EXTENSION SETS (April 6, 1987)
  • K870418 — MYA-1 AND MYT-1 MYELOGRAM TRAY (March 17, 1987)
  • K870417 — RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY (March 5, 1987)
  • K854095 — BIOPSY TRAY I & II (November 25, 1985)

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