Meadox Medicals, Div. Boston Scientific Corp.: FDA clearances and approvals
Meadox Medicals, Div. Boston Scientific Corp. has 53 FDA 510(k) clearances (first 1976, latest 1997), plus 1 PMA decision, across 16 product codes in 4 review panels. Median 510(k) review time: 101 days.
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 |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 15 | 15 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 14 | 14 |
| DQX | Wire, Guide, Catheter | 5 | 5 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 5 | 5 |
| EZN | Dilator, Catheter, Ureteral | 3 | 3 |
| FTL | Mesh, Surgical, Polymeric | 2 | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| DTB | Permanent Pacemaker Electrode | 1 | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 1 | 1 |
Plus 6 more product codes.
Review panels
Most recent Meadox Medicals, Div. Boston Scientific Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953647 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING | LIT | 1997-05-16 | 651 |
| K960766 | MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT | DYF | 1997-03-19 | 387 |
| K962433 | MEADOX EXXCEL EPTFE VASCULAR GRAFT | DSY | 1997-03-17 | 266 |
| K961847 | HEMASHIELD VANTAGE (VASCULAR GRAFT | DSY | 1997-01-22 | 254 |
| K962342 | HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH | DXZ | 1996-09-10 | 84 |
| K955460 | MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT | DSY | 1996-05-30 | 183 |
| K952884 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER | LIT | 1996-02-21 | 243 |
| K955349 | HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC | DXZ | 1996-02-14 | 85 |
| K953298 | MS CLASSIQUE BALLOON DIATATION CATHETER | LIT | 1996-02-08 | 209 |
| K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT | MAL | 1996-02-01 | 101 |
43 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P850054 | PMA | STRKYER KNEE AUGMENTATION GRAFT | 1988-12-30 |
Recalls
openFDA lists no recalls under a recalling firm named Meadox Medicals, Div. Boston Scientific Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances does Meadox Medicals, Div. Boston Scientific Corp. have?
Meadox Medicals, Div. Boston Scientific Corp. has 53 FDA 510(k) clearances (first 1976, latest 1997), plus 1 PMA decision, across 16 product codes in 4 review panels.
How long does FDA take to clear Meadox Medicals, Div. Boston Scientific Corp.'s 510(k)s?
The median time from FDA receipt to decision across Meadox Medicals, Div. Boston Scientific Corp.'s cleared 510(k)s is 101 days.
What devices does Meadox Medicals, Div. Boston Scientific Corp. make?
Its most frequent FDA product codes are DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 15); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 14); DQX (Wire, Guide, Catheter, 5).
Has Meadox Medicals, Div. Boston Scientific Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Meadox Medicals, Div. Boston Scientific Corp. Related entities may recall under other names.
Next steps
- See all 53 Meadox Medicals, Div. Boston Scientific Corp. clearances with predicates and recalls
- Run predicate analysis for product code DSY, Meadox Medicals, Div. Boston Scientific Corp.'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.