FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTRAL VEIN CATH. TRAY CC-20-1420
K Number: K833573
·
Decision Jan 11, 1984
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
16
Review Days
91
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
- CENTRAL VEIN CATH. TRAY CC-20-1420
- K Number
- K833573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Intermed, Inc.
- Date Received
- October 12, 1983
- Decision Date
- January 11, 1984
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQY), ordered by most recent decision date.
Amplatzer TorqVue Exchange System
FDA 510(k)
FDA Class 2
·Cardiovascular
Perfect-O Ostial Positioning Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer TorqVue Delivery System
FDA 510(k)
FDA Class 2
·Cardiovascular
Teleport Glide Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
FDA 510(k)
FDA Class 2
·Cardiovascular
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| 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 |
| K791427 | CATHETERIZATION TRAYS FOLEY AND URETHRAL | Sep 7, 1979 | Substantially Equivalent |
| K791426 | PERITONEAL PAC | Aug 28, 1979 | Substantially Equivalent |
| K781748 | IRRIGATION TRAY | Dec 12, 1978 | Substantially Equivalent |