510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961219Substantially Equivalent

Percutaneous Introducer System

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

K961219 is the FDA 510(k) clearance record for PERCUTANEOUS INTRODUCER SYSTEM, a class II device, cleared for Boston Scientific Corp on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show 15 recalls naming K961219.

Clearance record

Decision date
Received
(85 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Boston Scientific Corp One Boston Scientific Pl., Natick, MA
510(k) summary
Summary
Third party review
No

Clearances, product code GEH

Trailing 12 months
9 clearances under product code GEH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GEH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20262
March 20260
April 20262
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260