Natec Medical Ltd
Moka, MU
NATEC MEDICAL LTD appears in FDA device records in Moka, MU. FDA records list 12 510(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 12 510(k) clearances for Natec Medical Ltd between 2011 and 2025. The busiest year on record is 2015, with 5. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 2 |
| 2012 | 1 |
| 2015 | 5 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251915 | Amethyst HP PTA OTW 0.035 Catheter | LIT | Substantially Equivalent | |
| K241040 | Amethyst HP PTA OTW 0.035 Catheter | LIT | Substantially Equivalent | |
| K220410 | Ebony HP PTA OTW 0.035 Catheter | LIT | Substantially Equivalent | |
| K210012 | Tamarin Blue PTCA RX Dilatation Catheter | LOX | Substantially Equivalent | |
| K152230 | Ebony PTA .014 RX Pheripheral Dilatation Catheter | LIT | Substantially Equivalent | |
| K141933 | FILAO NC RX PTCA DILATATION CATHETER | LOX | Substantially Equivalent | |
| K143041 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter | LIT | Substantially Equivalent | |
| K143036 | Ebony PTA 0.035 Peripheral Dilatation Catheter | LIT | Substantially Equivalent | |
| K142459 | Ebony PTA 0.014 RX Peripheral Dilatation Catheter | LIT | Substantially Equivalent | |
| K112735 | TAMARIN BLUE PTCA RX DILATATION CATHETER | LOX | Substantially Equivalent | |
| K112513 | EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER | LIT | Substantially Equivalent | |
| K103354 | EBONY PTA .035 PERIPHERAL DILATATION CATHETER | LIT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004415014 | 3004415014 | NATEC MEDICAL LTD | Ava Technopark, Med tech road, Cote DOr Technopole, Minissy, Cote DOr, Moka 80829 MU | 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