COOK PACEMAKER CORP. 116 BIOPOLAR CARDI
FDA 510(k) clearance K843001 · decided 1984-07-30
Clearance details
- K-number
- K843001
- Device name
- COOK PACEMAKER CORP. 116 BIOPOLAR CARDI
- Applicant
- Cook Pacemaker Corp.
- Decision
- Unknown
- Date received
- 1984-07-30
- Decision date
- 1984-07-30
- Days to decision
- 0 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS. (P870054/S014) | Cook Pacemaker Corp. | 1995-07-12 |
| MODEL K (UNIPOLAR) & M (BIPOLAR) ENDOCARDIAL LEADS (P870054/S009) | Cook Pacemaker Corp. | 1990-10-31 |
| MODEL Q (UNIPOLAR) & R (BIPOLAR) ENDOCARDIAL LEADS (P870054/S010) | Cook Pacemaker Corp. | 1990-06-19 |
| KELVIN (R) PACING SYSTEM (P870054/S011) | Cook Pacemaker Corp. | 1990-03-19 |
| KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S005) | Cook Pacemaker Corp. | 1989-12-06 |
| KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S003) | Cook Pacemaker Corp. | 1989-09-19 |
| KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S006) | Cook Pacemaker Corp. | 1989-07-31 |
| KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S004) | Cook Pacemaker Corp. | 1989-06-20 |