Boston Scientific, Target: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Boston Scientific, Target” (first 1999, latest 2003), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Stryker, based on public ownership records.
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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | 11 | 11 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
| MJN | Catheter, Intravascular Occluding, Temporary | 1 | 1 |
| MMX | Device, Percutaneous Retrieval | 1 | 1 |
Review panels
- Neurology (11)
- Cardiovascular (7)
- Radiology (1)
Most recent Boston Scientific, Target 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031049 | GUGLIELMI DETACHABLE COIL (GDC) | HCG | 2003-08-01 | 121 |
| K031168 | MATRIX STRETCH RESISTANT DETACHABLE COIL | HCG | 2003-05-14 | 30 |
| K030475 | GDC STRETCH RESISTANT DETACHABLE COIL | HCG | 2003-03-14 | 29 |
| K022860 | ATLANTIS PV IMAGING CATHETER, MODEL 36456 | ITX | 2002-11-21 | 85 |
| K022357 | TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 | DQX | 2002-10-16 | 89 |
| K021494 | GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 | HCG | 2002-06-06 | 28 |
| K014109 | IN-TIME RETRIEVAL DEVICE | MMX | 2002-03-12 | 88 |
| K012985 | MATRIX DETACHABLE COILS | HCG | 2002-01-31 | 147 |
| K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 | DQY | 2001-12-06 | 22 |
| K010853 | GUIDER SOFTIP GUIDING CATHETER XF 5F | DQY | 2001-04-18 | 28 |
9 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2007-07-11.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Boston Scientific Corp (730 510(k)s)
- Boston Scientific Scimed, Inc. (35 510(k)s)
- Boston Medical Products, Inc. (33 510(k)s)
- Boston Surgical Products, Inc. (17 510(k)s)
- Boston Biomedica, Inc. (12 510(k)s)
- Boston Pacific Medical, Inc. (11 510(k)s)
- Boston Scientific Neuromodulation (10 510(k)s)
- Boston Medical Corp. (8 510(k)s)
- Boston Aesthetics, Inc. (6 510(k)s)
- Boston Scientific /International Technologies (5 510(k)s)
- Boston Scientific/Medi-Tech (5 510(k)s)
- Boston Brace Intl., Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Boston Scientific, Target?
FDA lists 19 510(k) clearances under the applicant name “Boston Scientific, Target” (first 1999, latest 2003), across 8 product codes in 3 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 Boston Scientific, Target?
The median time from FDA receipt to decision across 510(k)s cleared under the name Boston Scientific, Target is 88 days.
Which FDA product codes appear under Boston Scientific, Target?
The most frequent FDA product codes under this applicant name are HCG (Device, Neurovascular Embolization, 11); DQY (Catheter, Percutaneous, 2); DQO (Catheter, Intravascular, Diagnostic, 1).
Next steps
- See all 19 Boston Scientific, Target clearances with predicates and recalls
- Run predicate analysis for product code HCG, Boston Scientific, Target'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.