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510(k) K861877

BYRON WORD BARTHOLIAN GLAND CATHETER by Byron Medical — Product Code GBA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1986
Date Received
May 15, 1986
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

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  • K973133 — BIG BAG 3000 PRESSURE INFUSOR (September 12, 1997)
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Other clearances for product code GBA

  • K802025 — BALLOON RETENTION CHEST CATHETER (September 26, 1980)
  • K790444 — ELECATH MULTI-PURPOSE ARTERIAL SURGER (June 11, 1979)
  • K781772 — CATHETER, TRANSLUMINAL BALLOON (March 6, 1979)
  • K781665 — TUBE, LEATHERMAN/IMBRUCE (December 15, 1978)