510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K880860Substantially Equivalent

Coronary Ostium Occluder, Catalog Code 32015

Dlp, Inc., Grand Rapids MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880860 is the FDA 510(k) clearance record for CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015, a class II device, cleared for Dlp, Inc. on under FDA product code DQT (Occluder, Catheter Tip). FDA records list 39 510(k) clearances for Dlp, Inc., from to . As of , FDA records show no recalls naming K880860.

Clearance record

Decision date
Received
(86 days to decision)
Product code
DQT Occluder, Catheter Tip
Regulation
21 CFR 870.1370
Device class
Class II
Review panel
Cardiovascular
Applicant
Dlp, Inc. P.O.Box 409, Grand Rapids MI
Third party review
No

Clearances, product code DQT

Trailing 12 months

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

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