MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE
FDA 510(k) clearance K890988 · decided 1989-08-25
Clearance details
- K-number
- K890988
- Device name
- MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE
- Applicant
- Pace Medical
- Decision
- Substantially Equivalent
- Date received
- 1989-02-27
- Decision date
- 1989-08-25
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waltham, MA, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER (P920032/S008) | Pace Medical | 2002-02-20 |
| BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170 (P920032/S007) | Pace Medical | 2001-10-26 |
| MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER (P920032/S006) | Pace Medical | 2001-04-06 |
| MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER (P920032/S005) | Pace Medical | 2000-02-02 |
| MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S004) | Pace Medical | 1998-02-27 |
| MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S003) | Pace Medical | 1996-07-19 |
| MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER (P920032/S002) | Pace Medical | 1996-04-26 |
| MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S001) | Pace Medical | 1995-08-28 |