PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
FDA 510(k) clearance K093858 · decided 2010-04-02
Clearance details
- K-number
- K093858
- Device name
- PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
- Decision
- Substantially Equivalent
- Date received
- 2009-12-16
- Decision date
- 2010-04-02
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- DSA
- Device class
- 2
- Regulation number
- 870.2900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sylmar, CA, 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 |
|---|---|---|
| META AND TEMPO PACEMAKERS (P900070/S030) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2006-07-28 |
| META & TEMPO PACEMAKERS (P900070/S034) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2006-07-11 |
| META AND TEMPO PACEMAKERS (P900070/S032) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2006-04-28 |
| META AND TEMPO PACEMAKERS (P900070/S031) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2006-03-14 |
| APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A) (P900070/S028) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2003-01-22 |
| TRILOGY/SOLUS II/PARAGON III/PHOENIX III (P900070/S027) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2000-09-07 |
| TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO (P900070/S026) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2000-02-18 |
| R5.111WE(REVISION OF R5.85WE) (P900070/S025) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1999-09-24 |