FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK
K Number: K910861
·
Decision May 7, 1991
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
682
Applicant Total
63
Review Days
81
Basic Information
- Device Name
- PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK
- K Number
- K910861
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- DAIG CORP.
- Date Received
- February 15, 1991
- Decision Date
- May 7, 1991
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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