Synaptic Medical Corporation
Beijing, CN
SYNAPTIC MEDICAL CORPORATION appears in FDA device records in Beijing, CN. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Synaptic Medical Corporation between 2014 and 2024. The busiest year on record is 2024, with 3. The most recent is 2024, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 2 |
| 2015 | 1 |
| 2022 | 1 |
| 2024 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233900 | Nordica PV Cryo Mapping Catheter | DRF | Substantially Equivalent | |
| K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230) | DRC | Substantially Equivalent | |
| K233708 | NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) | DYB | Substantially Equivalent | |
| K203793 | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | DRF | Substantially Equivalent | |
| K151936 | Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle | DYB | Unknown | |
| K132943 | INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE | DRC | Substantially Equivalent | |
| K133028 | RITHM ID ELECTROPHYSIOLOGY CATHETER | DRF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013400708 | 3013400708 | SYNAPTIC MEDICAL CORPORATION | 1959 Kellogg Ave, Carlsbad, CA 92008 US | 2026 | |
| 3010200163 | 3010200163 | SYNAPTIC MEDICAL LIMITED | No.9 Tongji North Road, Beijing 100176 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain