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510(k) K802025

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

K802025 is an FDA 510(k) premarket notification submitted by Loseff Medical Designers, Ltd. for the device "BALLOON RETENTION CHEST CATHETER". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code GBA (Catheter, Balloon Type), a Class I device regulated under 21 CFR 878.4200. Loseff Medical Designers, Ltd. has at least 1 other 510(k) clearance on record.

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)

FDA data resources