Vygon Corp.
East Rutherford, NJ, US
Vygon Corp. appears in FDA device records in East Rutherford, NJ. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Vygon Corp. between 1985 and 1997. The busiest year on record is 1985, with 8. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 8 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1995 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K963196 | VYGON UMBILICAL CATHETHER INSERTION TRAY | FOZ | Substantially Equivalent | |
| K941678 | BIONECTOR | FOZ | Substantially Equivalent | |
| K883612 | LECTROSPIRAL | FPA | Substantially Equivalent | |
| K870067 | MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20 | DQY | Substantially Equivalent | |
| K860285 | XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE | KNT | Substantially Equivalent | |
| K851473 | VYGON DELEE SUCTION CATHETER CODE NO 533 | BSY | Substantially Equivalent | |
| K851479 | VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193 | CAZ | Substantially Equivalent | |
| K851005 | XRO UMBILICAL CATHETER-CODE 270 | FOS | Substantially Equivalent | |
| K851480 | VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW | LAE | Substantially Equivalent | |
| K851478 | VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183 | BSP | Substantially Equivalent | |
| K851474 | VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 | LAZ | Substantially Equivalent | |
| K851477 | VYGON EXCHANGE TRANSFUSION TRAY 275.00 | BRZ | Substantially Equivalent | |
| K851475 | VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5 | GBX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CAZAnesthesia Conduction Kit
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- GBXCatheter, Irrigation
- DQYCatheter, Percutaneous
- FOSCatheter, Umbilical Artery
- BSYCatheters, Suction, Tracheobronchial
- LAEHigh Pressure Liquid Chromatography, Codeine
- LAZN-Acetylprocainamide Control Materials
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FPASet, Administration, Intravascular
- BRZSet, Blood Transfusion
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain