Harbor Medical Devices, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Harbor Medical Devices, Inc. makes
Harbor Medical Devices, Inc. manufactures central venous catheters, including the HARBOR and HARBORIN variants, as well as vascular access systems like the S.E.A.-PORT and single-lumen versions. The company also produces infusion sets (SEA-PORT Infusion Set) and hypodermic needles (single lumen). Surgical accessory kits for the S.E.A.-PORT system are part of the portfolio.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Harbor Central Venous Catheter Ref K881884
Regimes: 510(k) Registry: 510(k)Sea - Port Infusion Set Ref K880297
Regimes: 510(k) Registry: 510(k)S.E.A.-Port(Tm) Vascular Access System Ref K882190
Regimes: 510(k) Registry: 510(k)Hypodermic Needles, Single Lumen Ref K874414
Regimes: 510(k) Registry: 510(k)Harbor S.E.A.-Port Surgical Accessory Kit Ref K882657
Regimes: 510(k) Registry: 510(k)Harborin Central Venous Catheter Ref K884628
Regimes: 510(k) Registry: 510(k)Single Lumen S.E.A.-Port Vascular Access System Ref K890518
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Harbor Medical Devices, Inc. have in the registry?
The registry currently lists 7 devices for Harbor Medical Devices, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Harbor Medical Devices, Inc.'s devices?
Among its 7 most recently registered devices, Harbor Medical Devices, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Harbor Medical Devices, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Harbor Medical Devices, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Harbor Medical Devices, Inc. in the registry?
The most recently registered devices listed for Harbor Medical Devices, Inc. include HARBOR CENTRAL VENOUS CATHETER, SEA - PORT INFUSION SET, S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM and HYPODERMIC NEEDLES, SINGLE LUMEN.