510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K041716Substantially Equivalent

PTFE Felts and Pledgets

Boston Scientific Corporation, Maple Grove MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041716 is the FDA 510(k) clearance record for PTFE FELTS AND PLEDGETS, a class II device, cleared for Boston Scientific Corp on under FDA product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K041716.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corp Two Scimed Pl., Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXZ

Trailing 12 months

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

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