510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053019Substantially Equivalent

Acuity Steerable Stylet Accessory

Boston Scientific Corporation, St Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053019 is the FDA 510(k) clearance record for ACUITY STEERABLE STYLET ACCESSORY, a class II device, cleared for Guidant Corporation on under FDA product code DRB (Stylet, Catheter). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K053019.

Clearance record

Decision date
Received
(128 days to decision)
Product code
DRB Stylet, Catheter
Regulation
21 CFR 870.1380
Device class
Class II
Review panel
Cardiovascular
Applicant
Guidant Corporation 4100 Hamline Ave. N, St Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRB

Trailing 12 months

FDA records hold no clearances under product code DRB in the trailing twelve months.

FDA records show no clearances under product code DRB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260