Safesept Needle Free Transseptal Trocar Guidewire
FDA 510(k) K130843 · Oscor, Inc.
510(k) numberK130843
Submission
- Device name
- Safesept Needle Free Transseptal Trocar Guidewire
- Applicant
- Oscor, Inc.
Palm Harbor, FL, US - Received
- March 27, 2013
- Decision date
- January 8, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
Other 510(k)s with product code DRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230)DRC · Traditional | Synaptic Medical Corporation | 07/26/2024SE |
| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)DRC · Special | Pressure Products Medical Device Manufacturing… | 05/17/2024SE |
| K221707 | SafeSept® Transseptal Guidewire (SS-140)DRC · Special | Pressure Products Medical Device Manufacturing… | 09/14/2022SE |
| K212625 | PathBuilder Transseptal NeedleDRC · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 03/23/2022SE |
| K210328 | SafeSept Blunt NeedleDRC · Special | Pressure Products Medical Device Manufacturing… | 03/05/2021SE |
| K172950 | TSN Transseptal NeedleDRC · Traditional | Pressure Products Medical Device Manufacturing… | 02/21/2018SE |
| K172934 | Needle Free Transseptal CannulaDRC · Traditional | Pressure Products Medical Device Manufacturing… | 02/16/2018SE |
| K172893 | SafeSept Needle Free Transseptal GuidewireDRC · Traditional | Pressure Products Medical Device Manufacturing… | 12/21/2017SE |
| K170671 | SafeSept Transseptal GuidewireDRC · Traditional | Pressure Products Medical Device Manufacturing… | 10/20/2017SE |
| K132943 | Intracardic Catheter Introducer Kit and Transseptal NeedleDRC · Traditional | Synaptic Medical Limited | 08/29/2014SE |
More from Synaptic Medical Limited
| 510(k) | Device | Decision |
|---|---|---|
| K210627 | Breezeway IIDYB · Special | 06/03/2021SE |
| K151951 | Destino ReachDYB · Special | 09/22/2015SE |
| K143463 | IS4/DF4 Port PlugDTD · Traditional | 03/19/2015SE |
| K140917 | Introducer, Model Adelante MagnumDYB · Traditional | 07/09/2014SE |
| K140406 | Destino Twist, Steerable Guiding SheathDYB · Special | 04/17/2014SE |
| K130633 | Introducer Sets, Model Adelante RadialDYB · Traditional | 02/13/2014SE |
| 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 Safesept Needle Free Transseptal Trocar Guidewire cleared by the FDA?
Safesept Needle Free Transseptal Trocar Guidewire (K130843) received a 510(k) decision of Substantially Equivalent on January 8, 2014, 287 days after the submission was received.
What is the product code of K130843?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.