FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOVASCULAR DISPOSABLE PRODUCTS
K Number: K830728
·
Decision Apr 28, 1983
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
2
Review Days
51
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
- CARDIOVASCULAR DISPOSABLE PRODUCTS
- K Number
- K830728
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Electromics, Inc.
- Date Received
- March 8, 1983
- Decision Date
- April 28, 1983
- Product Code
- DWF
- 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWF), ordered by most recent decision date.
Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae
FDA 510(k)
FDA Class 2
·Cardiovascular
Venous Return Cannulae
FDA 510(k)
FDA Class 2
·Cardiovascular
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
FDA 510(k)
FDA Class 2
·Cardiovascular
Retrograde Coronary Sinus Perfusion Cannulae
FDA 510(k)
FDA Class 2
·Cardiovascular
Dual Stage Venous Cannulae
FDA 510(k)
FDA Class 2
·Cardiovascular
Clearview Intracoronary Shunts
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Electromics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830727 | CARDIOTOMY RESERVOIR-FILTERED & NON | Apr 5, 1983 | Substantially Equivalent |