PERSONAL MEDICATION INFUSER
FDA 510(k) clearance K810850 · decided 1981-11-06
Clearance details
- K-number
- K810850
- Device name
- PERSONAL MEDICATION INFUSER
- Applicant
- Pacesetter Systems
- Decision
- Substantially Equivalent
- Date received
- 1981-03-30
- Decision date
- 1981-11-06
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, 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 |
|---|---|---|
| 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 |