Argon Medical Corp.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Argon Medical Corp.” (first 1976, latest 2013), across 21 product codes in 5 review panels. Median 510(k) review time under this name: 70 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 249 |
| 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 5 | 5 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| JCY | Catheter, Infusion | 2 | 2 |
| DOX | Fluorometer, Lead (Dedicated Instruments) | 1 | 1 |
| DQR | Cannula, Catheter | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DRC | Trocar | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DWO | Needle, Biopsy, Cardiovascular | 1 | 1 |
Plus 11 more product codes.
Review panels
- Cardiovascular (15)
- General and Plastic Surgery (5)
- Gastroenterology and Urology (4)
- General Hospital (2)
- Clinical Toxicology (1)
Most recent Argon Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130730 | V-STICK VASCULAR ACCESS SET | DYB | 2013-11-22 | 249 |
| K904994 | CLOSED SYSTEM FLUSH SET | DXT | 1991-01-15 | 69 |
| K895511 | CATHETER BALLOON DILATOR PRESSURE GAUGE | MAV | 1990-02-28 | 169 |
| K894157 | OBTURATOR | DYB | 1989-09-28 | 106 |
| K891022 | INTRODUCER FOR PTCA GUIDING CATHETERS | DYB | 1989-05-19 | 80 |
| K884375 | TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER | DQR | 1989-01-11 | 85 |
| K882221 | OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE | DYB | 1988-08-12 | 78 |
| K871297 | KADIR HI-TORQUE GUIDE WIRE | KOD | 1987-04-10 | 10 |
| K853312 | ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES | DWO | 1985-09-12 | 36 |
| K852880 | PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) | DYB | 1985-08-29 | 51 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Argon Medical Corp..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Argon Medical Corp. (a text match, not an official crosswalk):
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via JCY)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via JCY)
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.
- Argon Medical Devices, Inc. (25 510(k)s)
- Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG (3 510(k)s)
- Argon Med. Productions Vertriebs Gesellschaft Mbh (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Argon Medical Corp.?
FDA lists 28 510(k) clearances under the applicant name “Argon Medical Corp.” (first 1976, latest 2013), across 21 product codes in 5 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 Argon Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Argon Medical Corp. is 70 days.
Which FDA product codes appear under Argon Medical Corp.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 5); DQO (Catheter, Intravascular, Diagnostic, 3); JCY (Catheter, Infusion, 2).
Next steps
- See all 28 Argon Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Argon Medical Corp.'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.