STEERABLE STYLET
FDA 510(k) clearance K040001 · decided 2004-03-09
Clearance details
- K-number
- K040001
- Device name
- STEERABLE STYLET
- Applicant
- Synovis Surgical Innovations
- Decision
- Substantially Equivalent
- Date received
- 2004-01-02
- Decision date
- 2004-03-09
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- DRB
- Device class
- 2
- Regulation number
- 870.1380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St. Paul, 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 |
| 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 |
|---|---|---|
| DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT (P780002/S012) | Synovis Surgical Innovations | 1995-11-24 |
| DARDIK BIOGRAFT FOR PERIPHERAL & AV ACCESS USE (P780002/S008) | Synovis Surgical Innovations | 1990-09-11 |
| DARDIK BIOGRAFT (P780002/S005) | Synovis Surgical Innovations | 1986-05-19 |
| DARDIK BIOGRAFT (P780002/S002) | Synovis Surgical Innovations | 1981-12-01 |
| DARDIK BIOGRAFT (P780002/S004) | Synovis Surgical Innovations | 1981-11-30 |
| DARDIK BIOGRAFT FOR USE IN PERIPHERAL VASCULAR SUR (P780002/S001) | Synovis Surgical Innovations | 1981-07-10 |
| DARDIK BIOGRAFT (P780002) | Synovis Surgical Innovations | 1979-01-17 |