Shanghai MicroPort EP MedTech Co., Ltd.
Shanghai, CN
SHANGHAI MICROPORT EP MEDTECH CO., LTD. appears in FDA device records in Shanghai, CN. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. 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 4 510(k) clearances for Shanghai MicroPort EP MedTech Co., Ltd. in 2022.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | DRF | Substantially Equivalent | |
| K212626 | PathBuilder Transseptal Guiding Introducer | DYB | Substantially Equivalent | |
| K212625 | PathBuilder Transseptal Needle | DRC | Substantially Equivalent | |
| K211530 | PathBuilder Steerable Introducer | DYB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009393076 | 3009393076 | SHANGHAI MICROPORT EP MEDTECH CO., LTD. | Building 23&26&28, Lane 588, Tianxiong Rd., Shanghai 201318 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