510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K961999Substantially Equivalent

Schneider Guider Softip Guiding Catheters

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

K961999 is the FDA 510(k) clearance record for SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS, a class II device, cleared for Boston Scientific Scimed, Inc. on under FDA product code DYG (Catheter, Flow Directed). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K961999.

Clearance record

Decision date
Received
(181 days to decision)
Product code
DYG Catheter, Flow Directed
Regulation
21 CFR 870.1240
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Scimed, Inc. 5905 Nathan Ln., Plymouth MN
510(k) summary
Summary
Third party review
No

Clearances, product code DYG

Trailing 12 months

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

FDA records show no clearances under product code DYG in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DYG, 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