510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K883202Substantially Equivalent

Ultrasonic Imaging Catheter

Boston Scientific Corporation, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883202 is the FDA 510(k) clearance record for ULTRASONIC IMAGING CATHETER, a class II device, cleared for Boston Scientific Corp on under FDA product code DXO (Transducer, Pressure, Catheter Tip). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K883202.

Clearance record

Decision date
Received
(118 days to decision)
Product code
DXO Transducer, Pressure, Catheter Tip
Regulation
21 CFR 870.2870
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corp 2710 Orchard Pkwy., San Jose CA
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