GBA · Class I · 21 CFR 878.4200

FDA Product Code GBA: Catheter, Balloon Type

Leading manufacturers include Medi-Tech, Inc., Electro-Catheter Corp. and Byron Medical.

5
Total
5
Cleared
74d
Avg days
1978
Since

FDA 510(k) Cleared Catheter, Balloon Type Devices (Product Code GBA)

5 devices
1–5 of 5
Cleared May 30, 1986
BYRON WORD BARTHOLIAN GLAND CATHETER
K861877
Byron Medical
General & Plastic Surgery · 15d
Cleared Jun 11, 1979
ELECATH MULTI-PURPOSE ARTERIAL SURGER
K790444
Electro-Catheter Corp.
General & Plastic Surgery · 97d
Cleared Mar 06, 1979
CATHETER, TRANSLUMINAL BALLOON
K781772
Medi-Tech, Inc.
General & Plastic Surgery · 141d

About Product Code GBA - Regulatory Context