FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITALCARE FOLEY CATHETER
K Number: K021939
·
Decision Apr 22, 2003
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
127
Applicant Total
3
Review Days
314
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VITALCARE FOLEY CATHETER
- K Number
- K021939
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vitalcare, Inc.
- Date Received
- June 12, 2002
- Decision Date
- April 22, 2003
- Product Code
- EZL
- 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 |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EZL), ordered by most recent decision date.
Rusch SoftSimplastic Foley Catheters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Silicone Urethral Catheter (Silicone Urethral Catheter)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
InnoCare Specialty Foley Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Rüsch Latex Gold Foley Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TraumaGuard Intra-abdominal Pressure Sensing System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Folysil Silicone Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology