Medtronic Stylet Kit, Models 6282, 6293, and 6254
FDA 510(k) K010906 · Medtronic Vascular
510(k) numberK010906
Submission
- Device name
- Medtronic Stylet Kit, Models 6282, 6293, and 6254
- Applicant
- Medtronic Vascular
Shoreview, MN, US - Received
- March 26, 2001
- Decision date
- April 5, 2001
- 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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| 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 Medtronic Stylet Kit, Models 6282, 6293, and 6254 cleared by the FDA?
Medtronic Stylet Kit, Models 6282, 6293, and 6254 (K010906) received a 510(k) decision of Substantially Equivalent on April 5, 2001, 10 days after the submission was received.
What is the product code of K010906?
The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.