Accusafe Transseptal Guidewire (GTR31180, GTR31230)
FDA 510(k) K240246 · Synaptic Medical Corporation
510(k) numberK240246
Submission
- Device name
- Accusafe Transseptal Guidewire (GTR31180, GTR31230)
- Applicant
- Synaptic Medical Corporation
Carlsbad, CA, US - Received
- January 30, 2024
- Decision date
- July 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K130843 | Safesept Needle Free Transseptal Trocar GuidewireDRC · Traditional | Oscor, Inc. | 01/08/2014SE |
More from Oscor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233900 | Nordica PV Cryo Mapping CatheterDRF · Traditional | 09/06/2024SE |
| K233708 | NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)DYB · Traditional | 02/16/2024SE |
| K203793 | RithmID-SD Steerable Diagnostic Electrophysiology CatheterDRF · Traditional | 02/14/2022SE |
| K151936 | Steerable Intracardiac Catheter Introducer Kit and Transseptal NeedleDYB · Traditional | 12/04/2015SESK |
| K132943 | Intracardic Catheter Introducer Kit and Transseptal NeedleDRC · Traditional | 08/29/2014SE |
| K133028 | Rithm Id Electrophysiology CatheterDRF · Traditional | 03/04/2014SE |
Questions and answers
When was Accusafe Transseptal Guidewire (GTR31180, GTR31230) cleared by the FDA?
Accusafe Transseptal Guidewire (GTR31180, GTR31230) (K240246) received a 510(k) decision of Substantially Equivalent on July 26, 2024, 178 days after the submission was received.
What is the product code of K240246?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.