510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K041727Substantially Equivalent

Modification to Atlantis Pv Imaging Catheter, Model 36456

Boston Scientific Corporation, Fremont CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K041727 is the FDA 510(k) clearance record for MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456, a class II device, cleared for Boston Scientific Scimed, Inc. on under FDA product code OBJ (Catheter, Ultrasound, Intravascular). FDA's definition for product code OBJ reads: "For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology". FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K041727.

Clearance record

Decision date
Received
(28 days to decision)
Product code
OBJ Catheter, Ultrasound, Intravascular
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Scimed, Inc. 47900 Bayside Pkwy., Fremont CA
510(k) summary
Statement
Third party review
No

Clearances, product code OBJ

Trailing 12 months
4 clearances under product code OBJ in the twelve months to November 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OBJ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260
November 20260