Toray Anthron Angiographic Catheters
FDA 510(k) K872983 · Toray Industries (America), Inc.
510(k) numberK872983
Submission
- Device name
- Toray Anthron Angiographic Catheters
- Applicant
- Toray Industries (America), Inc.
New York, NY, US - Received
- July 31, 1987
- Decision date
- November 20, 1987
- 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 |
|---|---|---|
| K042370 | Torayguide GuidewireDQX · Traditional | 12/17/2004SE |
| K030050 | Toraysulfone Dialyzer, Bs-L SeriesKDI · Traditional | 09/29/2003SE |
| K002512 | Toraysulfone DialyzerKDI · Traditional | 10/15/2001SE |
| K994198 | Hemofeel-Ch, Models CH-0.35L, CH-0.6L, CH-1.0LKDI · Traditional | 08/25/2000SE |
| K942681 | FiltryzerKDI · Traditional | 06/22/1995SE |
| K935471 | Filtryzer(Tm)FJI · Traditional | 05/19/1995SE |
| K940910 | FiltryzerFJI · Traditional | 05/04/1995SE |
| K884339 | Toray Filtryzer DialyzersFJI · Traditional | 03/17/1989SE |
| K883407 | Toray Filtryzer BK SeriesKDI · Traditional | 02/27/1989SE |
| K884083 | Toray Vascular ProsthesisDSY · Traditional | 01/12/1989SE |
Questions and answers
When was Toray Anthron Angiographic Catheters cleared by the FDA?
Toray Anthron Angiographic Catheters (K872983) received a 510(k) decision of Substantially Equivalent on November 20, 1987, 112 days after the submission was received.
What is the product code of K872983?
The FDA product code is DQR – Cannula, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1300.