MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
FDA 510(k) clearance K080924 · decided 2008-04-30
Clearance details
- K-number
- K080924
- Device name
- MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
- Decision
- Substantially Equivalent
- Date received
- 2008-04-02
- Decision date
- 2008-04-30
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DRB
- Device class
- 2
- Regulation number
- 870.1380
- 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.
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|---|---|---|
| Arrow Stiffening Stylet (K220280) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022-08-30 |
| Biotronik Stylets (K191469) | Biotronik, Inc. | 2019-08-01 |
| GaltTWS (K182660) | Galt Medical Corp. | 2019-05-30 |
| Liberator Beacon Tip Locking Stylet (K170298) | Cook Incorporated | 2017-10-18 |
| LLD EZ (K142116) | Spectranetics, Inc. | 2014-08-12 |
| STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 (K090163) | St Jude Medical | 2009-04-01 |
| ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (K072864) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008-03-13 |
| ACUITY STEERABLE STYLET ACCESSORY (K053019) | Guidant Corporation | 2006-03-03 |
| EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (K052965) | Guidant Corporation | 2006-02-13 |
| SPECTRANETICS LLD CS, MODEL 518-039 (K043401) | Spectranetics Corp. | 2005-03-16 |
| STEERABLE STYLET (K040001) | Synovis Surgical Innovations | 2004-03-09 |
| MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 (K010906) | Medtronic Vascular | 2001-04-05 |
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 |