510(k) K897075

PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER by Pioneering Technologies, Inc. — Product Code DXC

K897075 is an FDA 510(k) premarket notification submitted by Pioneering Technologies, Inc. for the device "PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER". The FDA issued a decision of Substantially Equivalent on April 10, 1990. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Pioneering Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1990
Date Received
December 20, 1989
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