510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K112407Substantially Equivalent

Smith Medical Peel-Away Sheath Introducers

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

K112407 is the FDA 510(k) clearance record for SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS, a class II device, cleared for Smiths Medical MD, Inc. on under FDA product code DYB (Introducer, Catheter). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K112407.

Clearance record

Decision date
Received
(171 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Smiths Medical MD, Inc. 1265 Grey Fox Rd., St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DYB

Trailing 12 months
19 clearances under product code DYB in the twelve months to November 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20261
November 20260