Natec Medical , Ltd.: FDA clearances and approvals
Natec Medical , Ltd. has 12 FDA 510(k) clearances (first 2011, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time: 168 days. Since 2017 its median was 182 days, against 110 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 409 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 5 | 159 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 186 |
| 2022 | 1 | 135 |
| 2023 | 0 | — |
| 2024 | 1 | 246 |
| 2025 | 1 | 178 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Natec Medical , Ltd.'s cleared 510(k)s took a median 182 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 9 | 9 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 3 | 3 |
Review panels
- Cardiovascular (12)
Most recent Natec Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251915 | Amethyst HP PTA OTW 0.035 Catheter | LIT | 2025-12-18 | 178 |
| K241040 | Amethyst HP PTA OTW 0.035 Catheter | LIT | 2024-12-18 | 246 |
| K220410 | Ebony HP PTA OTW 0.035 Catheter | LIT | 2022-06-29 | 135 |
| K210012 | Tamarin Blue PTCA RX Dilatation Catheter | LOX | 2021-07-09 | 186 |
| K152230 | Ebony PTA .014 RX Pheripheral Dilatation Catheter | LIT | 2015-09-03 | 27 |
| K141933 | FILAO NC RX PTCA DILATATION CATHETER | LOX | 2015-06-28 | 347 |
| K143041 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter | LIT | 2015-06-04 | 225 |
| K143036 | Ebony PTA 0.035 Peripheral Dilatation Catheter | LIT | 2015-03-30 | 159 |
| K142459 | Ebony PTA 0.014 RX Peripheral Dilatation Catheter | LIT | 2015-02-03 | 154 |
| K112735 | TAMARIN BLUE PTCA RX DILATATION CATHETER | LOX | 2012-11-02 | 409 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Natec Medical , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Natec Medical , Ltd.'s product codes (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Frequently asked questions
How many FDA 510(k) clearances does Natec Medical , Ltd. have?
Natec Medical , Ltd. has 12 FDA 510(k) clearances (first 2011, latest 2025), across 2 product codes in 1 review panel.
How long does FDA take to clear Natec Medical , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Natec Medical , Ltd.'s cleared 510(k)s is 168 days. Since 2017: 182 days, versus 110 days for all cleared 510(k)s in the same product codes.
What devices does Natec Medical , Ltd. make?
Its most frequent FDA product codes are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 9); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 3).
Has Natec Medical , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Natec Medical , Ltd. Related entities may recall under other names.
Next steps
- See all 12 Natec Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LIT, Natec Medical , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.