Subclavian Jugular Catheter Set
FDA 510(k) K820102 · Luther Medical Products, Inc.
510(k) numberK820102
Submission
- Device name
- Subclavian Jugular Catheter Set
- Applicant
- Luther Medical Products, Inc.
Walker, MI, US - Received
- January 15, 1982
- Decision date
- January 29, 1982
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K982797 | Blunt T-Peel Introducer Model Number PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICBDYB · Traditional | 11/30/1998SE |
| K980090 | Onecath, L-Cath Catheter System, Model OC-(16-22 Ga., 5CM-60CM)LJS · Traditional | 03/24/1998SE |
| K974543 | L-Cath Modified Seldinger Technique Insertion/Catheter Exchange Kit PE-MST24-24 Ga. Kit…FOZ · Traditional | 02/10/1998SE |
| K940198 | L-Cath Connector AssemblyGCD · Traditional | 12/15/1994SE |
| K942103 | L-Cath Catheter System - Port L-CathLJT · Traditional | 07/26/1994SE |
| K930473 | Onecath L-Cath Catheter SystemLJS · Traditional | 04/07/1994SEKD |
| K925236 | L Cath(R) Catheter SystemLJS · Traditional | 03/22/1994SE |
| K920755 | L-Cath Peel Away System CatheterLJS · Traditional | 06/07/1993SE |
| K925979 | Dual Lumen L-Cath Catheter SystemDQX · Traditional | 05/27/1993SE |
| K924968 | L-Cath Peel-Away Catheter SystemFOZ · Traditional | 05/21/1993SE |
Questions and answers
When was Subclavian Jugular Catheter Set cleared by the FDA?
Subclavian Jugular Catheter Set (K820102) received a 510(k) decision of Substantially Equivalent on January 29, 1982, 14 days after the submission was received.
What is the product code of K820102?
The FDA product code is DQR – Cannula, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1300.