510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884628Substantially Equivalent

Harborin Central Venous Catheter

Harbor Medical Devices, Inc., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884628 is the FDA 510(k) clearance record for HARBORIN CENTRAL VENOUS CATHETER, a class II device, cleared for Harbor Medical Devices, Inc. on under FDA product code DQR (Cannula, Catheter). FDA records list 7 510(k) clearances for Harbor Medical Devices, Inc., from to . As of , FDA records show no recalls naming K884628.

Clearance record

Decision date
Received
(189 days to decision)
Product code
DQR Cannula, Catheter
Regulation
21 CFR 870.1300
Device class
Class II
Review panel
Cardiovascular
Applicant
Harbor Medical Devices, Inc. 25 Drydock Ave., Boston MA
Third party review
No

Clearances, product code DQR

Trailing 12 months

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

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