510(k) K863247

AXIOM TROCAR THORACIC CATHETER by Axiom Medical, Inc. — Product Code GBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1986
Date Received
August 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type