Nmt Medical, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Nmt Medical, Inc.” (first 2000, latest 2004), plus 1 PMA decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 72 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 1 | 1 |
| HCI | Applier, Aneurysm Clip | 1 | 1 |
| MLV | Transcatheter Septal Occluder | 1 | 0 |
Review panels
- Cardiovascular (2)
- Neurology (1)
Most recent Nmt Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K034025 | NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC | DYB | 2004-03-26 | 88 |
| K994191 | SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T | HCI | 2000-02-08 | 57 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P000049 | PMA | CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD | 2001-12-05 |
Recalls
openFDA lists no recalls under a recalling firm named Nmt Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nmt Medical, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Nmt Medical, Inc.” (first 2000, latest 2004), plus 1 PMA decision, across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nmt Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nmt Medical, Inc. is 72 days.
Which FDA product codes appear under Nmt Medical, Inc.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 1); HCI (Applier, Aneurysm Clip, 1); MLV (Transcatheter Septal Occluder, 1).
Next steps
- See all 2 Nmt Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Nmt Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.