PLACER MODEL 6232 STEERABLE STYLET
FDA 510(k) clearance K000955 · decided 2000-06-16
Clearance details
- K-number
- K000955
- Device name
- PLACER MODEL 6232 STEERABLE STYLET
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 2000-03-24
- Decision date
- 2000-06-16
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- DRB
- Device class
- 2
- Regulation number
- 870.1380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, 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.
| Record | Firm | Date |
|---|---|---|
| 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 |
| MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (K080924) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008-04-30 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089) | Medtronic Vascular | 2025-12-19 |
| Endurant II/IIs Stent Graft System (P100021/S131) | Medtronic Vascular | 2025-10-23 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129) | Medtronic Vascular | 2025-09-15 |
| Resolute Onyx (P160043/S088) | Medtronic Vascular | 2025-06-26 |
| Endurant Stent Graft System (P100021/S130) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072) | Medtronic Vascular | 2025-05-20 |
| Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069) | Medtronic Vascular | 2025-05-08 |