THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012
FDA 510(k) clearance K974475 · decided 1998-03-02
Clearance details
- K-number
- K974475
- Device name
- THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012
- Applicant
- Biocontrol Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-26
- Decision date
- 1998-03-02
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Indiana, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NEUROCONTROL FREEHAND II SYSTEM (P950035/S009) | Biocontrol Technology, Inc. | 2002-01-18 |
| NEUROCONTROL FREEHAND SYSTEM (P950035/S010) | Biocontrol Technology, Inc. | 2001-09-13 |
| NEUROCONTROL FREEHAND SYSTEM (P950035/S008) | Biocontrol Technology, Inc. | 2000-11-14 |
| NEUROCONTROL FREEHAND SYSTEM (P950035/S006) | Biocontrol Technology, Inc. | 2000-07-05 |
| NEUROCONTROL FREEHAND SYSTEM (P950035/S007) | Biocontrol Technology, Inc. | 2000-06-23 |
| NEUROCONTROL FREEHAND SYSTEM (P950035/S005) | Biocontrol Technology, Inc. | 2000-01-13 |
| NEUROCONTROL FREEHAND SYSTEM (P950035/S004) | Biocontrol Technology, Inc. | 1999-05-18 |
| NEUROCONTROL FREEHAND SYSTEM (P950035/S003) | Biocontrol Technology, Inc. | 1999-01-19 |