Arrow Intl., Inc.: FDA filings under this applicant name
FDA lists 110 510(k) clearances under the applicant name “Arrow Intl., Inc.” (first 1976, latest 2010), across 35 product codes in 7 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | 15 | 15 |
| CAZ | Anesthesia Conduction Kit | 11 | 11 |
| DQY | Catheter, Percutaneous | 11 | 11 |
| DYB | Introducer, Catheter | 9 | 9 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 8 | 8 |
| DQX | Wire, Guide, Catheter | 6 | 6 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 6 | 6 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 6 | 6 |
| FMI | Needle, Hypodermic, Single Lumen | 4 | 4 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 3 | 3 |
Plus 25 more product codes.
Review panels
- Cardiovascular (54)
- General Hospital (30)
- Anesthesiology (11)
- Gastroenterology and Urology (7)
- General and Plastic Surgery (5)
- Orthopedic (2)
- Clinical Toxicology (1)
Most recent Arrow Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100635 | ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 | LJS | 2010-08-27 | 175 |
| K093050 | ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 | DQY | 2009-12-18 | 79 |
| K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES | KKX | 2007-10-10 | 133 |
| K071998 | ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT | FMI | 2007-09-26 | 65 |
| K071111 | NON-ABSORBABLE SILK SUTURE | GAP | 2007-07-17 | 88 |
| K060309 | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES | DSP | 2006-04-06 | 58 |
| K042126 | PICC | LJS | 2004-08-27 | 21 |
| K041153 | SHARPSAWAY II LOCKING DISPOSABLE CUP | FMI | 2004-07-12 | 70 |
| K040801 | INTRA-AORTIC BALLOON (IAB) | DSP | 2004-05-06 | 38 |
| K040802 | HEMOSONIC 200HEMODYNAMIC MONITOR | DPN | 2004-04-28 | 30 |
100 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Arrow Intl., 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 International, Inc. (22 510(k)s)
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (8 510(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 Intl., Inc.?
FDA lists 110 510(k) clearances under the applicant name “Arrow Intl., Inc.” (first 1976, latest 2010), across 35 product codes in 7 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 Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arrow Intl., Inc. is 86 days.
Which FDA product codes appear under Arrow Intl., Inc.?
The most frequent FDA product codes under this applicant name are DSP (System, Balloon, Intra-Aortic And Control, 15); CAZ (Anesthesia Conduction Kit, 11); DQY (Catheter, Percutaneous, 11).
Next steps
- See all 110 Arrow Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSP, Arrow Intl., 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.