510(k) K931587

MULTI-PORT Y INTRODUCER SET by Thomas Medical Products, Inc. — Product Code DYB

K931587 is an FDA 510(k) premarket notification submitted by Thomas Medical Products, Inc. for the device "MULTI-PORT Y INTRODUCER SET". The FDA issued a decision of Substantially Equivalent on October 6, 1993. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Thomas Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1993
Date Received
March 31, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type