Intraflon, Intraflux, Intravalve
FDA 510(k) K813144 · Exco, Inc.
510(k) numberK813144
Submission
- Device name
- Intraflon, Intraflux, Intravalve
- Applicant
- Exco, Inc.
Mchenry, IL, US - Received
- November 5, 1981
- Decision date
- November 27, 1981
- 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 |
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|---|---|---|
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| K844175 | Enternal Feeding Tube-Polyurethane EF504KNT · Traditional | 01/02/1985SE |
| K844174 | Flexible Stainless Steel Stylet for Enternal FeediKNT · Traditional | 12/07/1984SE |
| K832628 | Vygon Thoracic Drainage-Various #'SKDD · Traditional | 01/30/1984SE |
| K831802 | Life Vac #2191 & 2192LJS · Traditional | 01/11/1984SE |
| K833079 | Centracath #130,135 & 137-HEMOCATH #FOZ · Traditional | 12/29/1983SE |
| K830910 | Manometer Set C.V.P. #S 298/299KRK · Traditional | 04/05/1983SE |
| K822879 | Enteral Nutrition 1KNT · Traditional | 11/16/1982SE |
| K822836 | Microflex-VenofluxFPA · Traditional | 10/15/1982SE |
| K822691 | Vygon Epidural Anaesthesia TrayCAZ · Traditional | 10/15/1982SE |
Questions and answers
When was Intraflon, Intraflux, Intravalve cleared by the FDA?
Intraflon, Intraflux, Intravalve (K813144) received a 510(k) decision of Substantially Equivalent on November 27, 1981, 22 days after the submission was received.
What is the product code of K813144?
The FDA product code is DQR – Cannula, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1300.