Biotronik Stylets
FDA 510(k) K191469 · Biotronik, Inc.
510(k) numberK191469
Submission
- Device name
- Biotronik Stylets
- Applicant
- Biotronik, Inc.
Lake Oswego, OR, US - Received
- June 3, 2019
- Decision date
- August 1, 2019
- 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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| K170298 | Liberator Beacon Tip Locking StyletDRB · Traditional | Cook Incorporated | 10/18/2017SE |
| K142116 | LLD EzDRB · Special | Spectranetics, Inc. | 08/12/2014SE |
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| 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 |
| K043401 | Spectranetics LLD CS, Model 518-039DRB · Traditional | Spectranetics Corp. | 03/16/2005SE |
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Questions and answers
When was Biotronik Stylets cleared by the FDA?
Biotronik Stylets (K191469) received a 510(k) decision of Substantially Equivalent on August 1, 2019, 59 days after the submission was received.
What is the product code of K191469?
The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.