510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980898Substantially Equivalent

Femostop II Disposable Set, Femostop II Compression Arch, Femostop II Pump, Femostop II Bilateral Adapter

Radi Medical Systems AB, Uppsala, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980898 is the FDA 510(k) clearance record for FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER, a class II device, cleared for Radi Medical Systems AB on under FDA product code DXC (Clamp, Vascular). FDA records list 24 510(k) clearances for Radi Medical Systems AB, from to . As of , FDA records show no recalls naming K980898.

Clearance record

Decision date
Received
(43 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Radi Medical Systems AB Palmbladsgatan 10, Uppsala, SE
510(k) summary
Summary
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