Occlusion & Occlusion-Irrigation
FDA 510(k) K844918 · Clincal Instruments Corp.
510(k) numberK844918
Submission
- Device name
- Occlusion & Occlusion-Irrigation
- Applicant
- Clincal Instruments Corp.
Dudley, MA, US - Received
- December 19, 1984
- Decision date
- August 5, 1985
- 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 |
| 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 |
More from Uresil Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K902327 | Embolectomy CatheterDXE · Traditional | 02/25/1991SE |
| K860743 | Carotid Bypass Shunt with Sampling ArmDWF · Traditional | 05/28/1986SE |
| K860742 | Carotid Bypass ShuntDWF · Traditional | 05/28/1986SE |
| K852704 | Tweetheart #102 Fetal/Neonatal Heartbeat AnnunciatHGM · Traditional | 11/26/1985SE |
| K821220 | Multilumen Intravenous Infusion CatheterGBP · Traditional | 07/09/1982SE |
| K790034 | IntroducersDYB · Traditional | 02/01/1979SE |
| K771043 | Swan GanzDYG · Traditional | 12/20/1977SE |
Questions and answers
When was Occlusion & Occlusion-Irrigation cleared by the FDA?
Occlusion & Occlusion-Irrigation (K844918) received a 510(k) decision of Substantially Equivalent on August 5, 1985, 229 days after the submission was received.
What is the product code of K844918?
The FDA product code is DQT – Occluder, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.1370.