510(k) K974568

CHASE ANASTOMOSIS VISUALIZATION DEVICE by Chase Medical, Inc. — Product Code FQH

K974568 is an FDA 510(k) premarket notification submitted by Chase Medical, Inc. for the device "CHASE ANASTOMOSIS VISUALIZATION DEVICE". The FDA issued a decision of Substantially Equivalent on January 6, 1998. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Chase Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1998
Date Received
December 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type