Intracardic Catheter Introducer Kit and Transseptal Needle
FDA 510(k) K132943 · Synaptic Medical Limited
510(k) numberK132943
Submission
- Device name
- Intracardic Catheter Introducer Kit and Transseptal Needle
- Applicant
- Synaptic Medical Limited
Shanghai, CN - Received
- September 19, 2013
- Decision date
- August 29, 2014
- 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 |
|---|---|---|---|
| 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 |
| 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 |
| K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230)DRC · Traditional | 07/26/2024SE |
| 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 |
| K133028 | Rithm Id Electrophysiology CatheterDRF · Traditional | 03/04/2014SE |
Questions and answers
When was Intracardic Catheter Introducer Kit and Transseptal Needle cleared by the FDA?
Intracardic Catheter Introducer Kit and Transseptal Needle (K132943) received a 510(k) decision of Substantially Equivalent on August 29, 2014, 344 days after the submission was received.
What is the product code of K132943?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.