Avd Intimax Occlusion Catheter
FDA 510(k) K910339 · Applied Vascular Devices, Inc.
510(k) numberK910339
Submission
- Device name
- Avd Intimax Occlusion Catheter
- Applicant
- Applied Vascular Devices, Inc.
Laguna Hills, CA, US - Received
- January 28, 1991
- Decision date
- May 29, 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 |
| K910916 | Cathlab Silicone Occlusion Balloon CatheterDQT · Traditional | Cathlab Corp. | 06/24/1991SE |
| 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 |
|---|---|---|
| K911730 | Surgical Obturator with SealGCJ · Traditional | 12/23/1991SE |
| K911589 | Disposable Surgical Trocar with SealGCJ · Traditional | 07/05/1991SE |
| K910372 | Intimax Thrombectomy CatheterDXE · Traditional | 04/26/1991SE |
| K911181 | Intimax(Tm) Irrigation CatheterGCA · Traditional | 04/18/1991SE |
| K910493 | Avd Intimax Cholangiography CatheterFGE · Traditional | 03/28/1991SE |
| K903848 | Diagnostic Intrascular CatheterDQO · Traditional | 03/25/1991SE |
| K905738 | Operative Cholangiographic CatheterFGE · Traditional | 03/21/1991SE |
| K910079 | Disposable Introducer SheathKDC · Traditional | 02/27/1991SE |
| K902256 | Irrigation Catheter 4, 6 and 10 FrenchDQY · Traditional | 02/15/1991SE |
| K904379 | Surgical Trocar and CannulaHET · Traditional | 12/21/1990SE |
Questions and answers
When was Avd Intimax Occlusion Catheter cleared by the FDA?
Avd Intimax Occlusion Catheter (K910339) received a 510(k) decision of Substantially Equivalent on May 29, 1991, 121 days after the submission was received.
What is the product code of K910339?
The FDA product code is DQT – Occluder, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.1370.