OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE
FDA 510(k) clearance K020896 · decided 2002-06-14
Clearance details
- K-number
- K020896
- Device name
- OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE
- Applicant
- Osypka Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-19
- Decision date
- 2002-06-14
- Days to decision
- 87 days
- Clearance type
- Abbreviated
- Product code
- DTE
- Device class
- 2
- Regulation number
- 870.3600
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- La Jolla, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Oscor PACE 203H, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 external recall (Z-2443-2010) | Osypka Medical Inc | 2010-09-21 |
| St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator The PACE 203H / Model recall (Z-2444-2010) | Osypka Medical Inc | 2010-09-21 |