NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
FDA 510(k) K233708 · Synaptic Medical Corporation
510(k) numberK233708
Submission
- Device name
- NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
- Applicant
- Synaptic Medical Corporation
Carlsbad, CA, US - Received
- November 20, 2023
- Decision date
- February 16, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) cleared by the FDA?
NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) (K233708) received a 510(k) decision of Substantially Equivalent on February 16, 2024, 88 days after the submission was received.
What is the product code of K233708?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.