510(k) K831716

CAPD - CATHETER ADAPTER by American Mcgaw — Product Code FKX

K831716 is an FDA 510(k) premarket notification submitted by American Mcgaw for the device "CAPD - CATHETER ADAPTER". The FDA issued a decision of Substantially Equivalent on June 24, 1983. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. American Mcgaw has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1983
Date Received
May 27, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type