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GBA — Catheter, Balloon Type Class I

FDA Device Classification

Classification Details

Product Code
GBA
Device Class
Class I
Regulation Number
878.4200
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K861877byron medicalBYRON WORD BARTHOLIAN GLAND CATHETERMay 30, 1986
K802025loseff medical designersBALLOON RETENTION CHEST CATHETERSeptember 26, 1980
K790444electro-catheterELECATH MULTI-PURPOSE ARTERIAL SURGERJune 11, 1979
K781772medi-techCATHETER, TRANSLUMINAL BALLOONMarch 6, 1979
K781665national catheter co. div. mallinckrodtTUBE, LEATHERMAN/IMBRUCEDecember 15, 1978