Harbor Central Venous Catheter
FDA 510(k) K881884 · Harbor Medical Devices, Inc.
510(k) numberK881884
Submission
- Device name
- Harbor Central Venous Catheter
- Applicant
- Harbor Medical Devices, Inc.
Boston, MA, US - Received
- May 4, 1988
- Decision date
- July 28, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQR – Cannula, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1300
- Specialty
- Cardiovascular
Other 510(k)s with product code DQR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131446 | Integra Jarit Heparin Cannulas, Injectors, and NeedlesDQR · Traditional | Integra LifeSciences Corporation | 10/28/2013SE |
| K073559 | 18 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula IIDQR · Special | Edwards Lifesciences Research Medical | 01/31/2008SE |
| K051655 | Angiodynamics, Inc., Micro Access KitsDQR · Traditional | AngioDynamics, Inc. | 09/12/2005SE |
| K030398 | Cardiacassist Transseptal Cannula Set, Model 5132-6221DQR · Traditional | Cardiacassist, Inc. | 05/23/2003SE |
| K960098 | Rmi Internal Mammary Artery CannulaDQR · Traditional | Research Medical, Inc. | 03/26/1996SE |
| K902674 | Datascope Arterial Cannula W/Access PortDQR · Traditional | Datascope Corp. | 01/16/1991SE |
| K894784 | Modified Shiley Femoral Venous CannulaDQR · Traditional | Shiley, Inc. | 03/28/1990SE |
| K894243 | Rmi Arterial Perfusion CannulaDQR · Traditional | Research Medical, Inc. | 09/19/1989SE |
| K884628 | Harborin Central Venous CatheterDQR · Traditional | Harbor Medical Devices, Inc. | 05/15/1989SE |
| K884478 | Daig Collapsible Sterile SleeveDQR · Traditional | Daig Corp. | 02/22/1989SE |
More from Daig Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K884628 | Harborin Central Venous CatheterDQR · Traditional | 05/15/1989SE |
| K890518 | Single Lumen S.E.A.-Port Vascular Access SystemLJT · Traditional | 04/21/1989SE |
| K882657 | Harbor S.E.A.-Port Surgical Accessory KitDYB · Traditional | 12/13/1988SE |
| K882190 | S.E.A.-Port(Tm) Vascular Access SystemLJT · Traditional | 06/09/1988SE |
| K880297 | Sea - Port Infusion SetLJT · Traditional | 02/19/1988SE |
| K874414 | Hypodermic Needles, Single LumenFMI · Traditional | 01/14/1988SE |
Questions and answers
When was Harbor Central Venous Catheter cleared by the FDA?
Harbor Central Venous Catheter (K881884) received a 510(k) decision of Substantially Equivalent on July 28, 1988, 85 days after the submission was received.
What is the product code of K881884?
The FDA product code is DQR – Cannula, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1300.