510(k) K925979

DUAL LUMEN L-CATH CATHETER SYSTEM by Luther Medical Products, Inc. — Product Code DQX

K925979 is an FDA 510(k) premarket notification submitted by Luther Medical Products, Inc. for the device "DUAL LUMEN L-CATH CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on May 27, 1993. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Luther Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1993
Date Received
November 25, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type