510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820446Substantially Equivalent

Catheter, Multiple Lumen

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

K820446 is the FDA 510(k) clearance record for CATHETER, MULTIPLE LUMEN, a class I device, cleared for Dlp, Inc. on under FDA product code GBP (Catheter, Multiple Lumen). FDA records list 5 510(k) clearances for Dlp, Inc., from to . As of , FDA records show no recalls naming K820446.

Clearance record

Decision date
Received
(21 days to decision)
Product code
GBP Catheter, Multiple Lumen
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Dlp, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GBP

Trailing 12 months

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

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