510(k) K982365

ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT by Geister Medizin Technik GmbH — Product Code DXC

K982365 is an FDA 510(k) premarket notification submitted by Geister Medizin Technik GmbH for the device "ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT". The FDA issued a decision of Substantially Equivalent on April 8, 1999. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Geister Medizin Technik GmbH has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1999
Date Received
July 7, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type