Steerable Stylet
FDA 510(k) K040001 · Synovis Surgical Innovations
510(k) numberK040001
Submission
- Device name
- Steerable Stylet
- Applicant
- Synovis Surgical Innovations
St. Paul, MN, US - Received
- January 2, 2004
- Decision date
- March 9, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRB – Stylet, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1380
- Specialty
- Cardiovascular
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| K220280 | Arrow Stiffening StyletDRB · Traditional | Arrow International, LLC (A subsidiary of… | 08/30/2022SE |
| K191469 | Biotronik StyletsDRB · Traditional | Biotronik, Inc. | 08/01/2019SE |
| K182660 | GaltTWSDRB · Traditional | Galt Medical Corp. | 05/30/2019SE |
| K170298 | Liberator Beacon Tip Locking StyletDRB · Traditional | Cook Incorporated | 10/18/2017SE |
| K142116 | LLD EzDRB · Special | Spectranetics, Inc. | 08/12/2014SE |
| K090163 | Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078DRB · Traditional | St Jude Medical | 04/01/2009SE |
| K080924 | Mond Rvot Stylet Models 4140, 4141, 4150, 4151DRB · Traditional | St. Jude Medical, Cardiac Rhythm Management Divisi | 04/30/2008SE |
| K072864 | St. Jude Medical, CPS Duo Left Heart Lead Delivery SystemDRB · Traditional | St. Jude Medical, Cardiac Rhythm Management Divisi | 03/13/2008SE |
| K053019 | Acuity Steerable Stylet AccessoryDRB · Traditional | Guidant Corporation | 03/03/2006SE |
| K052965 | Easytrak 2 Stylet, Models 4826, 4829, 4832.DRB · Traditional | Guidant Corporation | 02/13/2006SE |
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Questions and answers
When was Steerable Stylet cleared by the FDA?
Steerable Stylet (K040001) received a 510(k) decision of Substantially Equivalent on March 9, 2004, 67 days after the submission was received.
What is the product code of K040001?
The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.