Medical device manufacturer
Arrow Intl., Inc.
Arrow Intl., Inc. holds 110 FDA 510(k) clearances across 35 product codes. Median elapsed review time is 85 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 110
- Product codes
- 35
- Median review
- 85 days
- Recall records
- 0
How does FDA spell Arrow Intl., Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Arrow Intl., Inc. file in?
35 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | 15 | 87 days | |
| CAZ | Anesthesia Conduction Kit | 11 | 37 days | |
| DQY | Catheter, Percutaneous | 11 | 36 days | |
| DYB | Introducer, Catheter | 9 | 147 days | |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 8 | 80 days | |
| DQX | Wire, Guide, Catheter | 6 | 83 days | |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 6 | 187 days | |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 6 | 180 days | |
| FMI | Needle, Hypodermic, Single Lumen | 4 | 67 days | |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 3 | 286 days | |
| MPB | Catheter, Hemodialysis, Non-Implanted | 3 | 187 days | |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 5 days | |
| JOL | Catheter And Tip, Suction | 2 | 105 days | |
| KGZ | Accessories, Catheter | 2 | 24 days | |
| MCW | Catheter, Peripheral, Atherectomy | 2 | 53 days | |
| DPN | Thin Layer Chromatography, Propoxyphene | 1 | 30 days | |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 228 days | |
| DRC | Trocar | 1 | 203 days | |
| DXE | Catheter, Embolectomy | 1 | 75 days | |
| DXT | Injector And Syringe, Angiographic | 1 | 88 days | |
| DYG | Catheter, Flow Directed | 1 | 168 days | |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 59 days | |
| FMF | Syringe, Piston | 1 | 15 days | |
| FPA | Set, Administration, Intravascular | 1 | 169 days | |
| GAP | Suture, Nonabsorbable, Silk | 1 | 88 days |
Showing the 25 they file in most, of 35.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Arrow Intl., Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Arrow Intl., Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K100635 | ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 | LJS | 175 | |
| K093050 | ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 | DQY | 79 | |
| K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES | KKX | 133 | |
| K071998 | ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT | FMI | 65 | |
| K071111 | NON-ABSORBABLE SILK SUTURE | GAP | 88 | |
| K060309 | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES | DSP | 58 | |
| K042126 | PICC | LJS | 21 | |
| K041153 | SHARPSAWAY II LOCKING DISPOSABLE CUP | FMI | 70 | |
| K040801 | INTRA-AORTIC BALLOON (IAB) | DSP | 38 | |
| K040802 | HEMOSONIC 200HEMODYNAMIC MONITOR | DPN | 30 |
Source: openFDA device/510k · retrieved
Watch what Arrow Intl., Inc. files next
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