The Omniguide Guiding Catheter with Balloon
FDA 510(k) K945963 · Micro Interventional Systems, Inc.
510(k) numberK945963
Submission
- Device name
- The Omniguide Guiding Catheter with Balloon
- Applicant
- Micro Interventional Systems, Inc.
Sunnyvale, CA, US - Received
- December 7, 1994
- Decision date
- February 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K872090 | The Robicsek - Pruitt Aortic Balloon Occlusion KitDQT · Traditional | Ideas For Medicine, Inc. | 10/30/1987SE |
| 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 |
Questions and answers
When was The Omniguide Guiding Catheter with Balloon cleared by the FDA?
The Omniguide Guiding Catheter with Balloon (K945963) received a 510(k) decision of Substantially Equivalent on February 8, 1995, 63 days after the submission was received.
What is the product code of K945963?
The FDA product code is DQT – Occluder, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.1370.