Cathlab Silicone Occlusion Balloon Catheter
FDA 510(k) K910916 · Cathlab Corp.
510(k) numberK910916
Submission
- Device name
- Cathlab Silicone Occlusion Balloon Catheter
- Applicant
- Cathlab Corp.
Irvine, CA, US - Received
- March 5, 1991
- Decision date
- June 24, 1991
- 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 |
| 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 |
More from Clincal Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K910917 | Cathlab Silicone Biliary Balloon CatheterGCA · Traditional | 08/02/1991SE |
| K905139 | Cathlab Silicone Arterial Embolectomy CatheterDXE · Traditional | 02/25/1991SE |
| K897051 | Miller Percutaneous Angiographic/Scopic Irri. CathDQO · Traditional | 03/16/1990SE |
| K897184 | 3F and 4F Irrigation Embolectomy CathetersDXE · Traditional | 03/14/1990SE |
| K893435 | Silicone Flow-Directed Thermodilution CatheterDYG · Traditional | 09/26/1989SE |
| K893680 | Silicone Bi-Lumen Irrigation Embolectomy Cath.DXE · Traditional | 08/01/1989SE |
| K881455 | Embolectomy Catheter(Modified)DXE · Traditional | 06/15/1988SE |
Questions and answers
When was Cathlab Silicone Occlusion Balloon Catheter cleared by the FDA?
Cathlab Silicone Occlusion Balloon Catheter (K910916) received a 510(k) decision of Substantially Equivalent on June 24, 1991, 111 days after the submission was received.
What is the product code of K910916?
The FDA product code is DQT – Occluder, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.1370.