510(k) K021990

GALT MEDICAL GUIDEWIRE by Galt Medical Corp. — Product Code DQX

K021990 is an FDA 510(k) premarket notification submitted by Galt Medical Corp. for the device "GALT MEDICAL GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on July 18, 2002. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Galt Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2002
Date Received
June 18, 2002
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