DQT · Occluder, Catheter Tip
Cardiovascular · 21 CFR 870.1370 · Class 2
Overview
| Product Code | DQT |
|---|---|
| Device Name | Occluder, Catheter Tip |
| Regulation | 21 CFR 870.1370 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K983927 | GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT | Arterial Vascular Engineering, Inc. | Mar 11, 1999 | SESE |
| K945963 | THE OMNIGUIDE GUIDING CATHETER WITH BALLOON | Micro Interventional Systems, Inc. | Feb 8, 1995 | SESE |
| K910916 | CATHLAB SILICONE OCCLUSION BALLOON CATHETER | Cathlab Corp. | Jun 24, 1991 | SESE |
| K910339 | AVD INTIMAX OCCLUSION CATHETER | Applied Vascular Devices, Inc. | May 29, 1991 | SESE |
| K880860 | CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 | Dlp, Inc. | May 26, 1988 | SESE |
| K880231 | MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER | Ideas For Medicine, Inc. | May 25, 1988 | SESE |
| K872090 | THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT | Ideas For Medicine, Inc. | Oct 30, 1987 | SESE |
| K872790 | PERFUSION CATHETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 15, 1987 | SESE |
| K872154 | MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH | Ideas For Medicine, Inc. | Aug 3, 1987 | SESE |
| K863559 | URESIL OCCLUSION BALLOON CATHETER | Uresil Corp. | Oct 10, 1986 | SESE |
| K844918 | OCCLUSION & OCCLUSION-IRRIGATION | Clincal Instruments Corp. | Aug 5, 1985 | SESE |
| K840795 | ACS SOF-T GUIDE WIREE | Advanced Cardiovascular Systems, Inc. | Jul 2, 1984 | SESE |
Top Applicants
- Ideas For Medicine, Inc. — 3 clearances
- Advanced Cardiovascular Systems, Inc. — 1 clearance
- Applied Vascular Devices, Inc. — 1 clearance
- Arterial Vascular Engineering, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
