510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K971314Substantially Equivalent

Dcat Embolectomy Catheter System

Boston Scientific Corporation, Queensburgy NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971314 is the FDA 510(k) clearance record for DCAT EMBOLECTOMY CATHETER SYSTEM, a class II device, cleared for AngioDynamics, Inc. on under FDA product code DXE (Catheter, Embolectomy). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K971314.

Clearance record

Decision date
Received
(342 days to decision)
Product code
DXE Catheter, Embolectomy
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
AngioDynamics, Inc. 603 Queensbury Ave., Queensburgy NY
510(k) summary
Statement
Third party review
No

Clearances, product code DXE

Trailing 12 months

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

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