FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MANIFOLD
K Number: K972654
·
Decision Oct 8, 1997
Classifications
1
FEI Numbers
143
Registration Numbers
144
Same Product Code
136
Applicant Total
5
Review Days
85
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
- MANIFOLD
- K Number
- K972654
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Specialties Intl., Inc.
- Date Received
- July 15, 1997
- Decision Date
- October 8, 1997
- Product Code
- DTL
- 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 |
|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTL), ordered by most recent decision date.
Attachable Cath Lab Hemostasis Valve
FDA 510(k)
FDA Class 2
·Cardiovascular
Passage Hemostasis Valve
FDA 510(k)
FDA Class 2
·Cardiovascular
ROTATING ADAPTERS
FDA 510(k)
FDA Class 2
·Cardiovascular
COLIGN
FDA 510(k)
FDA Class 2
·Cardiovascular
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
FDA 510(k)
FDA Class 2
·Cardiovascular
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular