Home / 510(k) Clearances / K830711

510(k) K830711

TRACHESTOMY & NASAL SUCTIONING KIT #- by Intertex Medical — Product Code GBZ

K830711 is an FDA 510(k) premarket notification submitted by Intertex Medical for the device "TRACHESTOMY & NASAL SUCTIONING KIT #-". The FDA issued a decision of Substantially Equivalent on May 2, 1983. The device falls under product code GBZ (Catheter, Cholangiography), a Class I device regulated under 21 CFR 878.4200. Intertex Medical has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1983
Date Received
March 7, 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 Intertex Medical

  • K952824 — NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (July 20, 1995)

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)
  • K926143 — ANGIOLAPCATH CHOLANGIOGRAPHY KIT (July 7, 1993)
  • K924212 — STRYKER ENDOSCOPY CHOLANGIOGRAM 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