510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955349Substantially Equivalent

Hemashield Knitted Double Velour Cardiovascular Fabric

Meadox Medicals, Div. Boston Scientific Corp., Oakland NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955349 is the FDA 510(k) clearance record for HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC, a class II device, cleared for Meadox Medicals, Div. Boston Scientific Corp. on under FDA product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene). FDA records list 53 510(k) clearances for Meadox Medicals, Div. Boston Scientific Corp., from to . As of , FDA records show 2 recalls naming K955349.

Clearance record

Decision date
Received
(85 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
Meadox Medicals, Div. Boston Scientific Corp. 112 Bauer Dr., Oakland NJ
510(k) summary
Summary
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260