MODEL 220 PATIENT MAGNET
FDA 510(k) clearance K092364 · decided 2009-11-03
Clearance details
- K-number
- K092364
- Device name
- MODEL 220 PATIENT MAGNET
- Applicant
- Cyberonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-08-05
- Decision date
- 2009-11-03
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- DTG
- Device class
- 1
- Regulation number
- 870.3690
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Houston, TX, 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 |
|---|---|---|
| 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 |
| TEST MAGNET (K813153) | Pacesetter Systems | 1981-12-02 |
Recalls involving this device
No recalls on record reference this clearance.