Target Therapeutics: FDA filings under this applicant name
FDA lists 70 510(k) clearances under the applicant name “Target Therapeutics” (first 1985, latest 1998), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 100 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 22 | 22 |
| DQO | Catheter, Intravascular, Diagnostic | 10 | 10 |
| DQY | Catheter, Percutaneous | 10 | 10 |
| HCG | Device, Neurovascular Embolization | 9 | 9 |
| KRA | Catheter, Continuous Flush | 3 | 3 |
| KRD | Device, Vascular, For Promoting Embolization | 3 | 3 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 3 | 3 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 | 2 |
| DYB | Introducer, Catheter | 2 | 2 |
| MZQ | Balloon, Detachable, For Neurovascular Occlusion | 2 | 2 |
Plus 4 more product codes.
Review panels
- Cardiovascular (58)
- Neurology (11)
- General Hospital (1)
Most recent Target Therapeutics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965071 | DETACHABLE SLICONE BALLOON (DSB) | MZQ | 1998-04-21 | 488 |
| K964488 | DETACHABLE SILICONE BALLOON (DSB) | MZQ | 1998-04-21 | 529 |
| K964210 | RETRIEVER II | DQO | 1997-10-31 | 374 |
| K971395 | GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE | DQX | 1997-07-14 | 90 |
| K965189 | SPINNAKER | KRA | 1997-03-24 | 90 |
| K964112 | BERENSTEIN COIL | KRD | 1997-02-26 | 134 |
| K963307 | GDC PATIENT RETURN ELECTTRODE MODEL 45021 | HCG | 1996-12-17 | 117 |
| K962503 | GUGLIELMI DETACHABLE COIL | HCG | 1996-09-20 | 85 |
| K961923 | BERENSTEIN COIL | HCG | 1996-08-15 | 90 |
| K960705 | GUGLIELMI DETACHABLE COIL | HCG | 1996-05-21 | 90 |
60 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Target Therapeutics.
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.
- Target Health, Inc. (3 510(k)s)
- Target USA, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Target Therapeutics?
FDA lists 70 510(k) clearances under the applicant name “Target Therapeutics” (first 1985, latest 1998), across 14 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 Target Therapeutics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Target Therapeutics is 100 days.
Which FDA product codes appear under Target Therapeutics?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 22); DQO (Catheter, Intravascular, Diagnostic, 10); DQY (Catheter, Percutaneous, 10).
Next steps
- See all 70 Target Therapeutics clearances with predicates and recalls
- Run predicate analysis for product code DQX, Target Therapeutics'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.