510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K063871Substantially Equivalent

D-Stat Handle, Model 8500-053

Vascular Solutions LLC, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063871 is the FDA 510(k) clearance record for D-STAT HANDLE, MODEL 8500-053, a class II device, cleared for Vascular Solutions, Inc. on under FDA product code DXC (Clamp, Vascular). FDA records list 115 510(k) clearances for Vascular Solutions, Inc., from to . As of , FDA records show no recalls naming K063871.

Clearance record

Decision date
Received
(61 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Vascular Solutions, Inc. 6464 Sycamore Ct., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXC

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