FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER, SILICONE FOLEY (BARDEX)
K Number: K760093
·
Decision Aug 23, 1976
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
70
Applicant Total
645
Review Days
63
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Basic Information
- Device Name
- CATHETER, SILICONE FOLEY (BARDEX)
- K Number
- K760093
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- C.R. Bard, Inc.
- Date Received
- June 21, 1976
- Decision Date
- August 23, 1976
- Product Code
- GBM
- 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 |
|---|---|---|---|
| GBM | Catheter, Urethral | FDA class 2 | Gastroenterology, Urology |
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