FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTERIAL CANALIZATION DEVICE
K Number: K820516
·
Decision Apr 15, 1982
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
11
Review Days
49
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
- ARTERIAL CANALIZATION DEVICE
- K Number
- K820516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Alimed, Inc.
- Date Received
- February 25, 1982
- Decision Date
- April 15, 1982
- 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 Alimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963527 | UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS | Oct 31, 1996 | Substantially Equivalent |
| K963528 | ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) | Oct 29, 1996 | Substantially Equivalent |
| K963526 | STRAP WEDGE | Oct 28, 1996 | Substantially Equivalent |
| K920487 | MINI VIBRATOR | Feb 18, 1992 | Substantially Equivalent |
| K840156 | PROTECTA COAT SPONGES | Mar 23, 1984 | Substantially Equivalent |
| K822650 | SUPER DONUT | Sep 30, 1982 | Substantially Equivalent |
| K822651 | TOTAL FINGER FLEXION SPLINT | Sep 17, 1982 | Substantially Equivalent |
| K820517 | CONSTRUCTA FOAM | Mar 10, 1982 | Substantially Equivalent |
| K801743 | PLASTAZOTE SHOE | Aug 7, 1980 | Substantially Equivalent |
| K791189 | ECHO CARDIOGRAM PAD | Jul 17, 1979 | Substantially Equivalent |