510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K061484Substantially Equivalent

Modification to: Smithwick Carotid Shunt

Mcpherson Enterprises, Inc., Tampa FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K061484 is the FDA 510(k) clearance record for MODIFICATION TO: SMITHWICK CAROTID SHUNT, a class II device, cleared for Mcpherson Enterprises, Inc. on under FDA product code DXC (Clamp, Vascular). FDA records list 3 510(k) clearances for Mcpherson Enterprises, Inc., from to . As of , FDA records show no recalls naming K061484.

Clearance record

Decision date
Received
(191 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Mcpherson Enterprises, Inc. 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