Arrow International, Inc. (Subsidiary of Teleflex, Inc.): FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Arrow International, Inc. (Subsidiary of Teleflex, Inc.)” (first 2015, latest 2018), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 104 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 Teleflex, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 2 | 186 |
| 2016 | 4 | 85 |
| 2017 | 1 | 71 |
| 2018 | 1 | 269 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Arrow International, Inc. (Subsidiary of Teleflex, Inc.) took a median 170 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | 1 | 1 |
| PND | Midline Catheter | 1 | 1 |
Review panels
Most recent Arrow International, Inc. (Subsidiary of Teleflex, Inc.) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180395 | EZ-IO Intraosseous Vascular Access System | FMI | 2018-11-09 | 269 |
| K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System | FOZ | 2017-02-24 | 71 |
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology | PND | 2016-08-24 | 106 |
| K160018 | Arrow Quickflash Arterial Catheterization Device | DQX | 2016-06-13 | 160 |
| K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS | LJS | 2016-02-04 | 62 |
| K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC | LJS | 2016-01-28 | 64 |
| K152272 | Arrow Endurance Extended Dwell Peripheral Catheter System | FOZ | 2015-11-23 | 103 |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | NIE | 2015-07-24 | 268 |
Recalls
openFDA lists no recalls under a recalling firm named Arrow International, Inc. (Subsidiary of Teleflex, 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.
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.
- Arrow Intl., Inc. (110 510(k)s)
- Arrow International, Inc. (22 510(k)s)
- Arrow International (Subsidiary of Teleflex Inc.) (6 510(k)s)
- Arrow International, LLC (A subsidiary of Teleflex, Inc.) (4 510(k)s)
- Arrow International, Inc. (Subsidiary of Teleflex (2 510(k)s)
- Arrow X-Ray Corp. (2 510(k)s)
- Arrow Industries, LLC (1 510(k)s)
- Arrow Int'L. (1 510(k)s)
- Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) (1 510(k)s)
- Arrow International (A Subsidiary of Teleflex, Inc.) (1 510(k)s)
- Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) (1 510(k)s)
- Arrow International, Inc (Subsidiary of Teleflex I (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Arrow International, Inc. (Subsidiary of Teleflex, Inc.)?
FDA lists 8 510(k) clearances under the applicant name “Arrow International, Inc. (Subsidiary of Teleflex, Inc.)” (first 2015, latest 2018), across 6 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 Arrow International, Inc. (Subsidiary of Teleflex, Inc.)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arrow International, Inc. (Subsidiary of Teleflex, Inc.) is 104 days.
Which FDA product codes appear under Arrow International, Inc. (Subsidiary of Teleflex, Inc.)?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 2); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 8 Arrow International, Inc. (Subsidiary of Teleflex, Inc.) clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Arrow International, Inc. (Subsidiary of Teleflex, 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.