510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K971165Substantially Equivalent

Introducer Sheath and Dilator

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

K971165 is the FDA 510(k) clearance record for INTRODUCER SHEATH AND DILATOR, a class II device, cleared for Boston Scientific Corp on under FDA product code LDF (Electrode, Pacemaker, Temporary). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K971165.

Clearance record

Decision date
Received
(114 days to decision)
Product code
LDF Electrode, Pacemaker, Temporary
Regulation
21 CFR 870.3680
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corp One Boston Scientific Pl., Natick, MA
510(k) summary
Summary
Third party review
No

Clearances, product code LDF

Trailing 12 months
1 clearance under product code LDF in the twelve months to November 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LDF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260