Introducer Sets, Model Adelante Radial
FDA 510(k) K130633 · Oscor, Inc.
510(k) numberK130633
Submission
- Device name
- Introducer Sets, Model Adelante Radial
- Applicant
- Oscor, Inc.
Palm Harbor, FL, US - Received
- March 11, 2013
- Decision date
- February 13, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K140917 | Introducer, Model Adelante MagnumDYB · Traditional | 07/09/2014SE |
| K140406 | Destino Twist, Steerable Guiding SheathDYB · Special | 04/17/2014SE |
| K130843 | Safesept Needle Free Transseptal Trocar GuidewireDRC · Traditional | 01/08/2014SE |
| K130104 | Guidewire, Pursuer SeriesDQX · Traditional | 06/13/2013SE |
| K122960 | Steerable Guiding Sheath, Model Adelante DestinoDYB · Traditional | 12/13/2012SE |
| K122958 | Delivery Sheath, Model Adelante BreezewayDYB · Traditional | 12/13/2012SE |
| K122084 | Introducer Set, Model Adelante-S SeriesDYB · Special | 08/29/2012SE |
Questions and answers
When was Introducer Sets, Model Adelante Radial cleared by the FDA?
Introducer Sets, Model Adelante Radial (K130633) received a 510(k) decision of Substantially Equivalent on February 13, 2014, 339 days after the submission was received.
What is the product code of K130633?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.