FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETERIZATION TRAYS FOLEY AND URETHRAL
K Number: K791427
·
Decision Sep 7, 1979
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
16
Review Days
43
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Basic Information
- Device Name
- CATHETERIZATION TRAYS FOLEY AND URETHRAL
- K Number
- K791427
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Intermed, Inc.
- Date Received
- July 26, 1979
- Decision Date
- September 7, 1979
- Product Code
- KOD
- 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 |
|---|---|---|---|
| KOD | Catheter, Urological | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Intermed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K900857 | NON STERILE PARENTERAL SUPPLY KIT | May 22, 1990 | Unknown |
| K842166 | INTERMED, INS STERILE WATER/SALINE | Feb 12, 1985 | Substantially Equivalent |
| K833126 | DRESSING CHANGE TRAYS | Jan 27, 1984 | Substantially Equivalent |
| K833574 | PERCUTANEOUS SHEATH INTRODUCER TRAYS | Jan 11, 1984 | Substantially Equivalent |
| K833573 | CENTRAL VEIN CATH. TRAY CC-20-1420 | Jan 11, 1984 | Substantially Equivalent |
| K833139 | ACUTE HEMODIALYSIS TRAYS | Dec 22, 1983 | Substantially Equivalent |
| K833059 | SUCTION CATHETER TRAYS | Dec 12, 1983 | Substantially Equivalent |
| K821269 | TRACHEOSTOMY CARE TRAYS | May 27, 1982 | Substantially Equivalent |
| K791426 | PERITONEAL PAC | Aug 28, 1979 | Substantially Equivalent |
| K781748 | IRRIGATION TRAY | Dec 12, 1978 | Substantially Equivalent |