Van-Tec, Inc.
Walker, MI, US
Van-Tec, Inc. appears in FDA device records in Walker, MI. FDA records list 52 510(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
- 52
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 52FDA records hold 52 510(k) clearances for Van-Tec, Inc. between 1982 and 1988. The busiest year on record is 1987, with 18. The most recent is 1988, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 8 |
| 1983 | 6 |
| 1984 | 3 |
| 1985 | 4 |
| 1986 | 7 |
| 1987 | 18 |
| 1988 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K880099 | VAN-TEC BLADDER EVACUATOR | KQT | Substantially Equivalent | |
| K880098 | VAN-TEC AUTO BIOPSY NEEDLE | KNW | Substantially Equivalent | |
| K880096 | VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP | KNW | Substantially Equivalent | |
| K880095 | BERGER PROSTATE CULTURE CYTOLOGY BRUSH | FDX | Substantially Equivalent | |
| K880094 | VAN-TEC ENDOPYELOTOMY KNIFE | EMF | Substantially Equivalent | |
| K874112 | VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER | KOD | Substantially Equivalent | |
| K871779 | HELICAL STONE BASKET (DISPOSABLE) | FFL | Substantially Equivalent | |
| K871777 | VAN-TEC REUSABLE HELICAL STONE BASKET | FFL | Substantially Equivalent | |
| K870696 | VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH | FFL | Substantially Equivalent | |
| K870679 | VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE | FBO | Substantially Equivalent | |
| K870557 | VAN-TEC PUMPING SYSTEM | KOD | Substantially Equivalent | |
| K870735 | PROSTATIC ASPIRATION BIOPSY SET | KNW | Substantially Equivalent | |
| K870698 | VAN-TEC PROSTATE BIOPSY NEEDLE | KNN | Substantially Equivalent | |
| K870615 | VAN-TEC POSITIVE OPEN SEGURA BASKET | FFL | Substantially Equivalent | |
| K865087 | VAN-TEC DOUBLE SHEATH GRASPING FORCEPS | OCZ | Substantially Equivalent | |
| K865085 | KAMINSKY COMBINATION STENT & INJECTION CATHETER | FAD | Substantially Equivalent | |
| K870734 | TEFLON BIOPSY CATHETER W/TIP ANGLE | KNW | Substantially Equivalent | |
| K870697 | VAN-TEC ONE STEP URETERAL DILATATION CATHETER | EZN | Substantially Equivalent | |
| K870695 | VAN-TEC URETHRAL DILATATION SYSTEM | KOE | Substantially Equivalent | |
| K870694 | VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER | KOD | Substantially Equivalent | |
| K870556 | VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET | KOB | Substantially Equivalent | |
| K870555 | VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET | KOB | Substantially Equivalent | |
| K865086 | WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE | FBK | Substantially Equivalent | |
| K864874 | SEGURA DRETLER BASKET | FFL | Substantially Equivalent | |
| K860771 | VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE | GCQ | Substantially Equivalent | |
| K860946 | DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETER | FFL | Substantially Equivalent | |
| K860268 | VAN-TEC DEFLECTING GRASPING FORCEPS | FFL | Substantially Equivalent | |
| K860267 | MARDIS DANGLER URETERAL STENT SET | FAD | Substantially Equivalent | |
| K860337 | VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH. | KOD | Substantially Equivalent | |
| K860270 | VAN-TEC DEFLECTING ROTATING SEGURA BASKET | FFL | Substantially Equivalent | |
| K860269 | VAN-TEC DEFLECTING LOOP RETRIEVER | FFL | Substantially Equivalent | |
| K851160 | VAN-TEC GUIDE WIRE W/HYDROMER COATING | KOD | Substantially Equivalent | |
| K851162 | AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER | KOA | Substantially Equivalent | |
| K851158 | VAN-TEC MEATAL DILATOR | KOE | Substantially Equivalent | |
| K851144 | URETERAL DILATION SET | EZN | Substantially Equivalent | |
| K841941 | VAN-TEC OCCLUSION BALLOON CATHETER | KOD | Substantially Equivalent | |
| K841940 | VAN-TEC URETERAL DILATION BALLOON CATH | EZN | Substantially Equivalent | |
| K841942 | SEGURA BASKET | FFL | Substantially Equivalent | |
| K833242 | DEFLECTING GUIDE WIRE | KNY | Substantially Equivalent | |
| K832807 | PEDIATRIC ILLUMINATING URETERAL | FCW | Substantially Equivalent | |
| K832808 | URETERAL DILATION SET | EZN | Substantially Equivalent | |
| K830803 | URINARY DIVERSION STENT | LJE | Substantially Equivalent | |
| K830802 | LOOP RETRIEVER | OCZ | Substantially Equivalent | |
| K830840 | OPEN ENDED URETERAL CATHETER | GBM | Substantially Equivalent | |
| K822491 | DISPOSABLE GRASPING FORCEPS | GEN | Substantially Equivalent | |
| K822490 | DEFLECTING CYTOLOGY BRUSH | GEE | Substantially Equivalent | |
| K820869 | DISPOSABLE #11 SCALPEL BLADE W/SHORT | GDX | Substantially Equivalent | |
| K820865 | VAN-TEC FASCIAL DILATOR | GCC | Substantially Equivalent | |
| K820870 | URETERAL STANT SET | FAD | Substantially Equivalent | |
| K820868 | URETERAL CATHETER CONNECTOR | KOD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- GEEBrush, Biopsy, General & Plastic Surgery
- LJECatheter, Nephrostomy
- GBOCatheter, Nephrostomy, General & Plastic Surgery
- KOBCatheter, Suprapubic (And Accessories)
- GBMCatheter, Urethral
- KODCatheter, Urological
- KNNComponents, Wheelchair
- FBOCystourethroscope
- GCCDilator, Catheter
- EZNDilator, Catheter, Ureteral
- KOEDilator, Urethral
- FFLDislodger, Stone, Basket, Ureteral, Metal
- GCQEndoscope, Flexible
- FDXEndoscopic Cytology Brush
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- KQTEvacuator, Gastro-Urology
- GENForceps, General & Plastic Surgery
- KNWInstrument, Biopsy
- EMFKnife, Surgical
- FCWLight Source, Fiberoptic, Routine
- GDXScalpel, One-Piece
- FADStent, Ureteral
- KOASurgical Instruments, G-U, Manual (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
