SYNAPTIC MEDICAL LIMITED

FDA Device Registration & Listing · Beijing, CN · Registration 3010200163

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010200163
FEI Number
3010200163
Entity Name
SYNAPTIC MEDICAL LIMITED
City/State/Country
Beijing, CN
Establishment Address
No.9 Tongji North Road, Beijing Economic-Technological Development Area, Beijing 100176, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SYNAPTIC MEDICAL TECHNOLOGIES (BEIJING) CO.,LTD (Owner Number: 10052676)
Owner / Operator Contact Address
No.9 Tongji North Road, Beijing Economic-Technological Development Area, Beijing, CN-BJ 100176, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K133028
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2016-09-08
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2020-08-05
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2016-10-23

Official Correspondent

Rui Lv

US Agent Details

Ryan Kenney Email: ryan.kenney@synapticmed.com Phone: (760) 6851256

Related Public Records

Same Entity

SYNAPTIC MEDICAL TECHNOLOGIES (BEIJING) CO.,LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26
K122854 Arrow International (Subsidiary of Teleflex Inc.) ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 2013-01-04
K233691 Acutus Medical, Inc. FlexCath Cross Transseptal Solution 2023-12-17
K915078 North American Instrument Corp. MORSE HEMOSTATIC CATHETER INTRODUCER SET 1992-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

Similar Registrations

Registration Number Establishment Name Location
3017689643 CARDIOVIA Ltd. Nazareth Northern, IL
3041086754 PULNOVO MEDICAL (WUXI) CO., LTD. Wuxi Jiangsu, CN
3013764800 B. BRAUN MEDICAL INC. Allentown, PA, US
2020394 BARD PERIPHERAL VASCULAR, INC. TEMPE, AZ, US
3016904853 SAINT JONES MANAGEMENT LP EOOD Sofia Sofia-Grad, BG
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010200163. Last updated year: 2026. Please use registration number 3010200163 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.