FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VAN-TEC URETERAL DILATION BALLOON CATH
K Number: K841940
·
Decision Aug 3, 1984
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
55
Applicant Total
52
Review Days
84
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Basic Information
- Device Name
- VAN-TEC URETERAL DILATION BALLOON CATH
- K Number
- K841940
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5470
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Van-Tec, Inc.
- Date Received
- May 11, 1984
- Decision Date
- August 3, 1984
- Product Code
- EZN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EZN | Dilator, Catheter, Ureteral | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Van-Tec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880098 | VAN-TEC AUTO BIOPSY NEEDLE | Mar 2, 1988 | Substantially Equivalent |
| K880096 | VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP | Mar 2, 1988 | Substantially Equivalent |
| K880095 | BERGER PROSTATE CULTURE CYTOLOGY BRUSH | Mar 2, 1988 | Substantially Equivalent |
| K880099 | VAN-TEC BLADDER EVACUATOR | Mar 2, 1988 | Substantially Equivalent |
| K880094 | VAN-TEC ENDOPYELOTOMY KNIFE | Feb 29, 1988 | Substantially Equivalent |
| K874112 | VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER | Feb 11, 1988 | Substantially Equivalent |
| K871777 | VAN-TEC REUSABLE HELICAL STONE BASKET | Jun 17, 1987 | Substantially Equivalent |
| K871779 | HELICAL STONE BASKET (DISPOSABLE) | Jun 17, 1987 | Substantially Equivalent |
| K870679 | VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE | Mar 30, 1987 | Substantially Equivalent |
| K870557 | VAN-TEC PUMPING SYSTEM | Mar 30, 1987 | Substantially Equivalent |