American Heyer Schulte
Mchenry, IL, US
American Heyer Schulte appears in FDA device records in Mchenry, IL. 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 American Heyer Schulte between 1980 and 1984. The busiest year on record is 1983, with 4. The most recent is 1984, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1981 | 1 |
| 1982 | 2 |
| 1983 | 4 |
| 1984 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K840172 | VENTRAL WALL DEFECT REDUCT SILO | FTL | Substantially Equivalent | |
| K834593 | ONE-PIECE SHUNT | JXG | Substantially Equivalent | |
| K833502 | RADOVAN SUBCUTANEOUS TISSUE EXPANDER | LCJ | Substantially Equivalent | |
| K833698 | AMER. V. MUELLER SURG. STAPLES ILA | GDW | Substantially Equivalent | |
| K833704 | AMER. V. MUELLER SURGICALSTAPLES-CARTR | GDW | Substantially Equivalent | |
| K832738 | HEYER-SCHULTE AFTERLOADING CATHETER | IWJ | Substantially Equivalent | |
| K823790 | VENTRICULAR ACCESS SYSTEM | LKG | Substantially Equivalent | |
| K822096 | CHEMOTHERAPY INFUSION CATHETER | JCY | Substantially Equivalent | |
| K822032 | LARGE VOLUME CLOSED WOUND SUCTION DRAIN | GCY | Substantially Equivalent | |
| K820247 | EXTERNAL VENTRICULAR DRAINAGE SYS. | JXG | Substantially Equivalent | |
| K811288 | SPETZLER LUMBAR-PERITONEAL SYSTEM | JXG | Substantially Equivalent | |
| K802586 | AMERICAN HEYER-SCHULTE LOW PROFILE VALVE | JXG | Substantially Equivalent | |
| K801766 | JACKSON-PRATT LARGE VOL. CLOSED WOUND | GCY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- JCYCatheter, Infusion
- FTLMesh, Surgical, Polymeric
- LKGPort & Catheter, Implanted, Subcutaneous, Intraventricular
- JXGShunt, Central Nervous System And Components
- GDWStaple, Implantable
- IWJSystem, Applicator, Radionuclide, Manual
- LCJTissue Expander And Accessories
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