Home / 510(k) Clearances / K771219

510(k) K771219

BRONCHO-CATH by Mallinckrodt Critical Care — Product Code BTS

K771219 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "BRONCHO-CATH". The FDA issued a decision of Substantially Equivalent on August 4, 1977. The device falls under product code BTS (Tube, Bronchial (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5720. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1977
Date Received
July 5, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Bronchial (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5720
Review Panel
AN
Submission Type

Other clearances by Mallinckrodt Critical Care

  • K880343 — BURNEY GALLBLADDER CATHETER KIT (May 1, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)
  • K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE (January 29, 1988)
  • K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR (January 6, 1988)
  • K874404 — HI-LO TEMP(R) SKIN TEMPERATURE SENSOR (November 6, 1987)
  • K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) (November 6, 1987)
  • K873833 — THERMOCOUPLE ADAPTER (November 3, 1987)
  • K873004 — GUIDING CATHETER (September 15, 1987)
  • K871204 — CUFFED TRACHEAL TUBE (MULTIPLE) (April 21, 1987)
  • K862666 — UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) (August 1, 1986)

Other clearances for product code BTS

  • K953963 — RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIA (November 27, 1995)
  • K951091 — RUSCH ENDOBRONCHIAL TUBE SETS (June 8, 1995)
  • K902116 — MODIFIED ENDOBRONCHIAL TUBE (August 3, 1990)
  • K834565 — ENDOBRONCHIAL TWIN LUMEN TUBE (January 17, 1984)
  • K833297 — BRONCHOSCOPY TUBE W/ULTRA LOCUFF (December 27, 1983)

FDA data resources