510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983506Substantially Equivalent

Pressurewire Sensor, Model #12001

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

K983506 is the FDA 510(k) clearance record for PRESSUREWIRE SENSOR, MODEL #12001, a class II device, cleared for Radi Medical Systems AB on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 24 510(k) clearances for Radi Medical Systems AB, from to . As of , FDA records show no recalls naming K983506.

Clearance record

Decision date
Received
(119 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
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 DQX

Trailing 12 months
12 clearances under product code DQX in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20260