MAESTRO PACEMAKER TEST MAGNET
FDA 510(k) clearance K895110 · decided 1989-09-26
Clearance details
- K-number
- K895110
- Device name
- MAESTRO PACEMAKER TEST MAGNET
- Applicant
- Cardiac Control Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-15
- Decision date
- 1989-09-26
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- DTG
- Device class
- 1
- Regulation number
- 870.3690
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Palm Coast, FL, 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 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| POLY-SAFE(TM) A-TRACK(TM) PACING LEADS (P890039/S016) | Cardiac Control Systems, Inc. | 1998-11-09 |
| MAESTRO(R) II MODEL 534 PACEMAKER SYSTEM (P860027/S012) | Cardiac Control Systems, Inc. | 1997-07-29 |
| MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM (P860027/S011) | Cardiac Control Systems, Inc. | 1996-07-09 |
| MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333 (P890039/S015) | Cardiac Control Systems, Inc. | 1996-07-09 |
| MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM (P860027/S010) | Cardiac Control Systems, Inc. | 1995-09-26 |
| MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333 (P890039/S014) | Cardiac Control Systems, Inc. | 1995-05-16 |
| CCS MODEL 325 PACEMAKER SYSTEM (P890039/S012) | Cardiac Control Systems, Inc. | 1994-12-02 |
| MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333 (P890039/S013) | Cardiac Control Systems, Inc. | 1994-04-29 |