Harbor S.E.A.-Port Surgical Accessory Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K882657 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Harbor Central Venous Catheter

  Class II

  FDA 510(k) K881884 Active Cleared 28 Jul 1988

• Sea - Port Infusion Set

  Class II

  FDA 510(k) K880297 Active Cleared 19 Feb 1988

• S.E.A.-Port(Tm) Vascular Access System

  Class II

  FDA 510(k) K882190 Active Cleared 9 Jun 1988

• Hypodermic Needles, Single Lumen (K874414)

  Class II

  FDA 510(k) K874414 Active Cleared 14 Jan 1988

• Harborin Central Venous Catheter

  Class II

  FDA 510(k) K884628 Active Cleared 15 May 1989

• Single Lumen S.E.a.-Port Vascular Access System

  Class II

  FDA 510(k) K890518 Active Cleared 21 Apr 1989

• What is the primary clinical application for the Harbor S.E.A.-Port Surgical Accessory Kit?

  This accessory kit is specifically indicated for use during embolization procedures. It is classified as a Class 2 medical device and is categorized under product code DYB within the cardiovascular advisory committee scope.

• What is the regulatory status of this device?

  The Harbor S.E.A.-Port Surgical Accessory Kit received FDA 510(k) clearance under submission number K882657. The device was determined to be substantially equivalent to existing predicate devices through a traditional review process.

• Who is the manufacturer of the S.E.A.-Port Surgical Accessory Kit?

  The device is manufactured by Harbor Medical Devices, Inc., located at 25 Drydock Ave., Boston, MA, 02210, USA.