ACS SOF-T GUIDE WIREE
FDA 510(k) clearance K840795 · decided 1984-07-02
Clearance details
- K-number
- K840795
- Device name
- ACS SOF-T GUIDE WIREE
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-23
- Decision date
- 1984-07-02
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- DQT
- Device class
- 2
- Regulation number
- 870.1370
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT (K983927) | Arterial Vascular Engineering, Inc. | 1999-03-11 |
| THE OMNIGUIDE GUIDING CATHETER WITH BALLOON (K945963) | Micro Interventional Systems, Inc. | 1995-02-08 |
| CATHLAB SILICONE OCCLUSION BALLOON CATHETER (K910916) | Cathlab Corp. | 1991-06-24 |
| AVD INTIMAX OCCLUSION CATHETER (K910339) | Applied Vascular Devices, Inc. | 1991-05-29 |
| CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 (K880860) | Dlp, Inc. | 1988-05-26 |
| MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER (K880231) | Ideas For Medicine, Inc. | 1988-05-25 |
| THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT (K872090) | Ideas For Medicine, Inc. | 1987-10-30 |
| PERFUSION CATHETER (K872790) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-09-15 |
| MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH (K872154) | Ideas For Medicine, Inc. | 1987-08-03 |
| URESIL OCCLUSION BALLOON CATHETER (K863559) | Uresil Corp. | 1986-10-10 |
| OCCLUSION & OCCLUSION-IRRIGATION (K844918) | Clincal Instruments Corp. | 1985-08-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CORONARY DILATATION CATHETERS (P810046/S240) | Advanced Cardiovascular Systems, Inc. | 2010-10-15 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S237) | Advanced Cardiovascular Systems, Inc. | 2010-06-01 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S238) | Advanced Cardiovascular Systems, Inc. | 2010-05-13 |
| SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETERS VOYAGER/VOYAGER NC (P810046/S236) | Advanced Cardiovascular Systems, Inc. | 2010-04-23 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S234) | Advanced Cardiovascular Systems, Inc. | 2010-03-26 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S232) | Advanced Cardiovascular Systems, Inc. | 2010-02-04 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S230) | Advanced Cardiovascular Systems, Inc. | 2009-07-15 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S231) | Advanced Cardiovascular Systems, Inc. | 2009-05-26 |