510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760151Substantially Equivalent

Applicator,angiography (7310Mobin-Uddin)

Edwards Laboratories, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760151 is the FDA 510(k) clearance record for APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN), a class II device, cleared for Edwards Laboratories on under FDA product code DTK (Filter, Intravascular, Cardiovascular). FDA records list 12 510(k) clearances for Edwards Laboratories, from to . As of , FDA records show no recalls naming K760151.

Clearance record

Decision date
Received
(56 days to decision)
Product code
DTK Filter, Intravascular, Cardiovascular
Regulation
21 CFR 870.3375
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DTK

Trailing 12 months

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

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