510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K021608Substantially Equivalent

Smithwick Carotid Shunt

Implantable Devices, Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K021608 is the FDA 510(k) clearance record for SMITHWICK CAROTID SHUNT, a class II device, cleared for Implantable Devices on under FDA product code DXC (Clamp, Vascular). FDA records list one 510(k) clearance for Implantable Devices. As of , FDA records show no recalls naming K021608.

Clearance record

Decision date
Received
(159 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Implantable Devices P.O. Box 270882, Tampa FL
510(k) summary
Statement
Third party review
No

Clearances, product code DXC

Trailing 12 months
6 clearances under product code DXC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260