510(k) K992174

PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP by Pilling Weck Surgical — Product Code DXC

K992174 is an FDA 510(k) premarket notification submitted by Pilling Weck Surgical for the device "PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP". The FDA issued a decision of Substantially Equivalent on March 23, 2000. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Pilling Weck Surgical has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2000
Date Received
June 28, 1999
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