Occluder, Catheter Tip
The Catheter Tip Occluder is a cardiovascular accessory device used to temporarily block the tip or lumen of a catheter during vascular procedures to prevent backflow of blood or other fluids. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQT and it is regulated under 21 CFR 870.1370 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
Research product code DQT in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- DQT
- Device Class
- FDA class 2
- Regulation Number
- 870.1370
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K983927 | GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT | Mar 11, 1999 | Substantially Equivalent | Arterial Vascular Engineering, Inc. |
| K945963 | THE OMNIGUIDE GUIDING CATHETER WITH BALLOON | Feb 08, 1995 | Substantially Equivalent | Micro Interventional Systems, Inc. |
| K910916 | CATHLAB SILICONE OCCLUSION BALLOON CATHETER | Jun 24, 1991 | Substantially Equivalent | Cathlab Corp. |
| K910339 | AVD INTIMAX OCCLUSION CATHETER | May 29, 1991 | Substantially Equivalent | Applied Vascular Devices, Inc. |
| K880860 | CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 | May 26, 1988 | Substantially Equivalent | Dlp, Inc. |
| K880231 | MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER | May 25, 1988 | Substantially Equivalent | Ideas For Medicine, Inc. |
| K872090 | THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT | Oct 30, 1987 | Substantially Equivalent | Ideas For Medicine, Inc. |
| K872790 | PERFUSION CATHETER | Sep 15, 1987 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K872154 | MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH | Aug 03, 1987 | Substantially Equivalent | Ideas For Medicine, Inc. |
| K863559 | URESIL OCCLUSION BALLOON CATHETER | Oct 10, 1986 | Substantially Equivalent | Uresil Corp. |
| K844918 | OCCLUSION & OCCLUSION-IRRIGATION | Aug 05, 1985 | Substantially Equivalent | Clincal Instruments Corp. |
| K840795 | ACS SOF-T GUIDE WIREE | Jul 02, 1984 | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.