510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K113584Substantially Equivalent

Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver

Abbott Medical, Westford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113584 is the FDA 510(k) clearance record for PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER, a class II device, cleared for St Jude Medical on under FDA product code DXO (Transducer, Pressure, Catheter Tip). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K113584.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DXO Transducer, Pressure, Catheter Tip
Regulation
21 CFR 870.2870
Device class
Class II
Review panel
Cardiovascular
Applicant
St Jude Medical 4 Robbins Rd., Westford MA
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 November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXO, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260