510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K863427Substantially Equivalent

Clampease Fa

Freund Medical Products, Dayton OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863427 is the FDA 510(k) clearance record for CLAMPEASE FA, a class II device, cleared for Freund Medical Products on under FDA product code DXC (Clamp, Vascular). FDA records list one 510(k) clearance for Freund Medical Products. As of , FDA records show no recalls naming K863427.

Clearance record

Decision date
Received
(77 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Freund Medical Products 401 E. Fifth St., Dayton OH
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