Argon Medical Corp.
Gainesville, FL, US
Argon Medical Corp. appears in FDA device records in Gainesville, FL. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Argon Medical Corp. between 1976 and 2013. The busiest year on record is 1978, with 6. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 1 |
| 1978 | 6 |
| 1979 | 1 |
| 1982 | 1 |
| 1983 | 5 |
| 1985 | 5 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130730 | V-STICK VASCULAR ACCESS SET | DYB | Substantially Equivalent | |
| K904994 | CLOSED SYSTEM FLUSH SET | DXT | Substantially Equivalent | |
| K895511 | CATHETER BALLOON DILATOR PRESSURE GAUGE | MAV | Substantially Equivalent | |
| K894157 | OBTURATOR | DYB | Substantially Equivalent | |
| K891022 | INTRODUCER FOR PTCA GUIDING CATHETERS | DYB | Substantially Equivalent | |
| K884375 | TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER | DQR | Substantially Equivalent | |
| K882221 | OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE | DYB | Substantially Equivalent | |
| K871297 | KADIR HI-TORQUE GUIDE WIRE | KOD | Substantially Equivalent | |
| K853312 | ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES | DWO | Substantially Equivalent | |
| K852880 | PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) | DYB | Substantially Equivalent | |
| K844555 | PATHFINDER CARDIOVASCULAR CATHETER | DQO | Substantially Equivalent | |
| K842039 | ARGON DUAL LUMEN HEMODIALYSIS, CATHETER | KNZ | Substantially Equivalent | |
| K841926 | HYDROGLIDE SPRING GUIDE WIRES | DQX | Substantially Equivalent | |
| K833303 | DUOFLO 6F | DQY | Substantially Equivalent | |
| K832030 | HEPARIN COATED STAINLESS STEEL/TEFLON | DOX | Substantially Equivalent | |
| K831453 | SILCATH CENTRAL CATHETER TRAY W/18 GA | JCY | Substantially Equivalent | |
| K831451 | SILCATH CENTRAL CATHETER TRAY SIZE- | JCY | Substantially Equivalent | |
| K831171 | DIGICATH | DQO | Substantially Equivalent | |
| K820883 | SEPTISLEEVE | DYG | Substantially Equivalent | |
| K790353 | ACUTE RENAL DIALYSIS TRAY | FKG | Substantially Equivalent | |
| K781333 | CENTRAL CATHETER TRAY | KGC | Substantially Equivalent | |
| K780871 | ARTERIAL LINE KIT | GDY | Substantially Equivalent | |
| K780673 | CENTRAL CATHETER KIT | FPK | Substantially Equivalent | |
| K780259 | CATHETERIZATION TRAY & KIT | KGZ | Substantially Equivalent | |
| K780126 | DILATOR, VESSEL & INTRODUCER, SHEATH | DRE | Substantially Equivalent | |
| K772369 | NEEDLES USED IN ANGIOGRAPHIC PROCED. | DRC | Substantially Equivalent | |
| K770290 | MONITORING KIT, CENTRAL VENOUS PRESSURE | DQO | Substantially Equivalent | |
| K760498 | TRAY, DISPOSABLE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNZAccessories, A-V Shunt
- KGZAccessories, Catheter
- DQRCannula, Catheter
- DYGCatheter, Flow Directed
- JCYCatheter, Infusion
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- KODCatheter, Urological
- DREDilator, Vessel, For Percutaneous Catheterization
- DOXFluorometer, Lead (Dedicated Instruments)
- GDYGauze/Sponge, Internal, X-Ray Detectable
- DXTInjector And Syringe, Angiographic
- DYBIntroducer, Catheter
- DWONeedle, Biopsy, Cardiovascular
- MAVSyringe, Balloon Inflation
- FKGTray, Start/Stop (Including Contents), Dialysis
- DRCTrocar
- KGCTube, Gastro-Enterostomy
- FPKTubing, Fluid Delivery
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain