The Robicsek - Pruitt Aortic Balloon Occlusion Kit
FDA 510(k) K872090 · Ideas For Medicine, Inc.
510(k) numberK872090
Submission
- Device name
- The Robicsek - Pruitt Aortic Balloon Occlusion Kit
- Applicant
- Ideas For Medicine, Inc.
Clearwater, FL, US - Received
- June 1, 1987
- Decision date
- October 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQT – Occluder, Catheter Tip
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1370
- Specialty
- Cardiovascular
Other 510(k)s with product code DQT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983927 | GT1 Floppy, GT1 Hi-Per Flex, GT1 Light SupportDQT · Traditional | Arterial Vascular Engineering, Inc. | 03/11/1999SE |
| K945963 | The Omniguide Guiding Catheter with BalloonDQT · Traditional | Micro Interventional Systems, Inc. | 02/08/1995SE |
| K910916 | Cathlab Silicone Occlusion Balloon CatheterDQT · Traditional | Cathlab Corp. | 06/24/1991SE |
| K910339 | Avd Intimax Occlusion CatheterDQT · Traditional | Applied Vascular Devices, Inc. | 05/29/1991SE |
| K880860 | Coronary Ostium Occluder, Catalog Code 32015DQT · Traditional | Dlp, Inc. | 05/26/1988SE |
| K880231 | Modified Pruitt Irrigation & Occlusion CatheterDQT · Traditional | Ideas For Medicine, Inc. | 05/25/1988SE |
| K872790 | Perfusion CatheterDQT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/15/1987SE |
| K872154 | Modified Info Inserts for Pruitt Irri.-Occlu. CathDQT · Traditional | Ideas For Medicine, Inc. | 08/03/1987SE |
| K863559 | Uresil Occlusion Balloon CatheterDQT · Traditional | Uresil Corp. | 10/10/1986SE |
| K844918 | Occlusion & Occlusion-IrrigationDQT · Traditional | Clincal Instruments Corp. | 08/05/1985SE |
More from Clincal Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K961883 | Versa-Cath Arterial CatheterDXE · Traditional | 01/13/1997SE |
| K962751 | Ideas' Dual PortLJT · Traditional | 09/30/1996SE |
| K961716 | Vaso-Safe Arterial Embolectomy CatheteDXE · Traditional | 09/19/1996SE |
| K960715 | Pruitt-Inahara Carotid Shunt 400-40-8F/INAHARA-PRUITT Carotid Shunt 500-50-8FMJN · Traditional | 09/09/1996SE |
| K960422 | Pruitt Safety Occlusion CatheterMJN · Traditional | 08/07/1996SE |
| K954713 | Dural-Lumen Intra Vascular Balloon Catheter (Modification)FGE · Traditional | 07/24/1996SE |
| K935964 | Ideas OccluderDXC · Traditional | 01/04/1995SE |
| K935023 | Godat Uterine Manipulator InjectorLKF · Traditional | 01/04/1995SE |
| K880231 | Modified Pruitt Irrigation & Occlusion CatheterDQT · Traditional | 05/25/1988SE |
| K872485 | Change of Catheter Body Material (Radio-Opaque Ny)DXE · Traditional | 08/12/1987SE |
Questions and answers
When was The Robicsek - Pruitt Aortic Balloon Occlusion Kit cleared by the FDA?
The Robicsek - Pruitt Aortic Balloon Occlusion Kit (K872090) received a 510(k) decision of Substantially Equivalent on October 30, 1987, 151 days after the submission was received.
What is the product code of K872090?
The FDA product code is DQT – Occluder, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.1370.