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510(k) K822096

CHEMOTHERAPY INFUSION CATHETER by American Heyer Schulte — Product Code JCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
July 16, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Infusion
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

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  • K822032 — LARGE VOLUME CLOSED WOUND SUCTION DRAIN (August 16, 1982)
  • K820247 — EXTERNAL VENTRICULAR DRAINAGE SYS. (February 18, 1982)
  • K811288 — SPETZLER LUMBAR-PERITONEAL SYSTEM (June 26, 1981)

Other clearances for product code JCY

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  • K760760 — CATHETER, INTRAVASCULAR (ARGYLE IV SK) (December 9, 1976)
  • K760391 — CATHETER, VEIN (BRAUNULA) (November 2, 1976)