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510(k) K802025

BALLOON RETENTION CHEST CATHETER by Loseff Medical Designers, Ltd. — Product Code GBA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
August 20, 1980
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 Loseff Medical Designers, Ltd.

  • K801349 — LOSEFF BALLOON TYPE SELF-RETENTION WOUND (August 7, 1980)

Other clearances for product code GBA

  • K861877 — BYRON WORD BARTHOLIAN GLAND CATHETER (May 30, 1986)
  • K790444 — ELECATH MULTI-PURPOSE ARTERIAL SURGER (June 11, 1979)
  • K781772 — CATHETER, TRANSLUMINAL BALLOON (March 6, 1979)
  • K781665 — TUBE, LEATHERMAN/IMBRUCE (December 15, 1978)