TEST MAGNET
FDA 510(k) clearance K813153 · decided 1981-12-02
Clearance details
- K-number
- K813153
- Device name
- TEST MAGNET
- Applicant
- Pacesetter Systems
- Decision
- Substantially Equivalent
- Date received
- 1981-11-06
- Decision date
- 1981-12-02
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- DTG
- Device class
- 1
- Regulation number
- 870.3690
- 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 |
|---|---|---|
| MODEL 220 PATIENT MAGNET (K092364) | Cyberonics, Inc. | 2009-11-03 |
| MAGNO ALARM (K960849) | Cardiac Assist Devices, Inc. | 1997-03-26 |
| MAESTRO PACEMAKER TEST MAGNET (K895110) | Cardiac Control Systems, Inc. | 1989-09-26 |
| IMPLANTABLE ENDOCARDIAL PACING LEADS (K831926) | Oscor, Inc. | 1984-03-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CARBON TIP CARDIAC PACING LEAD (P800041/S015) | Pacesetter Systems | 1996-01-04 |
| CARBON TIP CARDIAC PACING LEAD (P800041/S014) | Pacesetter Systems | 1994-10-17 |
| CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S011) | Pacesetter Systems | 1994-05-25 |
| CARBON TIPPED LEAD ALT.PROD.TRAYS (P800041/S012) | Pacesetter Systems | 1992-11-18 |
| CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S010) | Pacesetter Systems | 1990-12-18 |
| CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S009) | Pacesetter Systems | 1990-12-10 |
| ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S008) | Pacesetter Systems | 1989-06-19 |
| ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S007) | Pacesetter Systems | 1987-06-22 |