FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HANCOCK * OBTURATORS
K Number: K801885
·
Decision Sep 9, 1980
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
6
Applicant Total
5
Review Days
33
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
- HANCOCK * OBTURATORS
- K Number
- K801885
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.3945
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Hancock Laboratories, Inc.
- Date Received
- August 7, 1980
- Decision Date
- September 9, 1980
- Product Code
- DTI
- 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 |
|---|---|---|---|
| DTI | Sizer, Heart-Valve, Prosthesis | FDA class 1 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTI), ordered by most recent decision date.
CARBOMEDICS SUPRA-ANNULAR VALVE SIZER
FDA 510(k)
FDA Class 1
·Cardiovascular
VALVE SIZER
FDA 510(k)
FDA Class 1
·Cardiovascular
EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
FDA 510(k)
FDA Class 1
·Cardiovascular
DUROMEDICS CARDIAC VALVE SIZER SET
FDA 510(k)
FDA Class 1
·Cardiovascular
METRONIC MODEL F7700 HEART VALVE SIZERS
FDA 510(k)
FDA Class 1
·Cardiovascular
MITRAL VALVE ORIFICE SIZER
FDA 510(k)
FDA Class 1
·Cardiovascular