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510(k) K781665

TUBE, LEATHERMAN/IMBRUCE by National Catheter Co. Div. Mallinckrodt — Product Code GBA

K781665 is an FDA 510(k) premarket notification submitted by National Catheter Co. Div. Mallinckrodt for the device "TUBE, LEATHERMAN/IMBRUCE". The FDA issued a decision of Substantially Equivalent on December 15, 1978. The device falls under product code GBA (Catheter, Balloon Type), a Class I device regulated under 21 CFR 878.4200. National Catheter Co. Div. Mallinckrodt has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1978
Date Received
September 28, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by National Catheter Co. Div. Mallinckrodt

  • K802918 — ANTHRON CATHETER SET (April 21, 1981)
  • K802505 — DOUBLE LUMEN TRACHEAL TUBE (March 13, 1981)
  • K810321 — REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) (March 4, 1981)
  • K801924 — HI-LO TEMP GEN. PURPOSE TEMP. PROBE (September 9, 1980)
  • K801005 — MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) (May 23, 1980)
  • K791190 — STETHOSCOPE WITH TEMPERATURE SENSOR (July 6, 1979)
  • K770727 — MANIPULATOR & INJECTOR, UTERINE (April 26, 1977)

Other clearances for product code GBA

  • K861877 — BYRON WORD BARTHOLIAN GLAND CATHETER (May 30, 1986)
  • K802025 — BALLOON RETENTION CHEST CATHETER (September 26, 1980)
  • K790444 — ELECATH MULTI-PURPOSE ARTERIAL SURGER (June 11, 1979)
  • K781772 — CATHETER, TRANSLUMINAL BALLOON (March 6, 1979)

FDA data resources