510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080813Substantially Equivalent

Pressurewire Certus, Certus (300Cm), Aeris, Aeris (300Cm), Receiver

Radi Medical Systems AB, Uppsala, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080813 is the FDA 510(k) clearance record for PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER, a class II device, cleared for Radi Medical Systems AB on under FDA product code DXO (Transducer, Pressure, Catheter Tip). FDA records list 24 510(k) clearances for Radi Medical Systems AB, from to . As of , FDA records show no recalls naming K080813.

Clearance record

Decision date
Received
(102 days to decision)
Product code
DXO Transducer, Pressure, Catheter Tip
Regulation
21 CFR 870.2870
Device class
Class II
Review panel
Cardiovascular
Applicant
Radi Medical Systems AB Palmbladsgatan 10, Uppsala, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXO

Trailing 12 months
1 clearance under product code DXO in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260