Data / Medical devices / China / Synaptic Medical Limited
Synaptic Medical Limited: FDA-registered device maker in Beijing, China, 2 510(k) clearances
Synaptic Medical Limited is registered with the FDA (registration 3010200163) in Beijing, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 4, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010200163
- Address
- No.9 Tongji North Road Beijing Economic-Technological Development Area, Beijing, China, 100176
- Owner or operator
- SYNAPTIC MEDICAL TECHNOLOGIES (BEIJING) CO.,LTD (10052676)
- Roles
- Manufacturer
- First device listed
- September 8, 2016
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Guidewire, Catheter, Reprocessed | NKQ | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
| Trocar | DRC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 4, 2015 | K151936 | Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle | DYB | Unknown | Synaptic Medical Limited | accessdata.fda.gov |
| August 29, 2014 | K132943 | INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE | DRC | Substantially Equivalent | Synaptic Medical Limited | accessdata.fda.gov |
Compare with other makers
Updated December 4, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.