Data / Medical devices / China / Shanghai Microport Ep Medtech Co., Ltd.
Shanghai Microport Ep Medtech Co., Ltd.: FDA-registered device maker in Shanghai, China, 4 510(k) clearances
Shanghai Microport Ep Medtech Co., Ltd. is registered with the FDA (registration 3009393076) in Shanghai, China. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 30, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009393076
- Address
- Building 23&26&28, Lane 588, Tianxiong Rd., Shanghai, China, 201318
- Owner or operator
- Shanghai MicroPort EP MedTech Co., Ltd. (10085214)
- Roles
- Manufacturer
- First device listed
- May 20, 2022
- Registered through
- 2026
- Brand names listed
- EasyFinder Fixed Curve Diagnostic Catheter, FORLNK Cable for Mapping Catheter, PathBuilder Steerable Introducer, PathBuilder Transseptal Guiding Introducer, PathBuilder Transseptal Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 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 30, 2022 | K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | DRF | Substantially Equivalent | Shanghai Microport EP Medtech Co., Ltd. | accessdata.fda.gov |
| March 23, 2022 | K212626 | PathBuilder Transseptal Guiding Introducer | DYB | Substantially Equivalent | Shanghai Microport EP Medtech Co., Ltd. | accessdata.fda.gov |
| March 23, 2022 | K212625 | PathBuilder Transseptal Needle | DRC | Substantially Equivalent | Shanghai Microport EP Medtech Co., Ltd. | accessdata.fda.gov |
| February 8, 2022 | K211530 | PathBuilder Steerable Introducer | DYB | Substantially Equivalent | Shanghai Microport EP Medtech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Catheter
- All makers of Catheter, Electrode Recording, Or Probe, Electrode Recording
- All makers of Trocar
Updated December 30, 2022. 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.