510(k) K983927
- Device
- GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
- Applicant
- ARTERIAL VASCULAR ENGINEERING, INC.
- 510(k) number
- K983927
- Product code
- DQT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-03-11
- Date received
- 1998-11-05
- Regulation
- 870.1370
- Classification name
- Occluder, Catheter Tip
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBORAH L HERRINGTON
- Address
- 129 Concord Rd. Billerica MA US 01821 01821
FDA Registration Numbers#
- 1220948
- 3010041511
- 3011137372
- 1319639
Source Documents#
Other 510(k) Records For Product Code DQT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K945963 | THE OMNIGUIDE GUIDING CATHETER WITH BALLOON | Micro Interventional Systems, Inc. | 1995-02-08 |
| K910916 | CATHLAB SILICONE OCCLUSION BALLOON CATHETER | Cathlab Corp. | 1991-06-24 |
| K910339 | AVD INTIMAX OCCLUSION CATHETER | Applied Vascular Devices, Inc. | 1991-05-29 |
| K880860 | CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 | Dlp, Inc. | 1988-05-26 |
| K880231 | MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER | Ideas For Medicine, Inc. | 1988-05-25 |
| K872090 | THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT | Ideas For Medicine, Inc. | 1987-10-30 |
| K872790 | PERFUSION CATHETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-09-15 |
| K872154 | MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH | Ideas For Medicine, Inc. | 1987-08-03 |
| K863559 | URESIL OCCLUSION BALLOON CATHETER | Uresil Corp. | 1986-10-10 |
| K844918 | OCCLUSION & OCCLUSION-IRRIGATION | Clincal Instruments Corp. | 1985-08-05 |
| K840795 | ACS SOF-T GUIDE WIREE | Advanced Cardiovascular Systems, Inc. | 1984-07-02 |
Legacy Summary#
summary
FDA Review#
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