510(k) K031277

JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 by Jomed, Inc. — Product Code DQX

K031277 is an FDA 510(k) premarket notification submitted by Jomed, Inc. for the device "JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002". The FDA issued a decision of Substantially Equivalent on May 14, 2003. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Jomed, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2003
Date Received
April 22, 2003
Clearance Type
Special
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