FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
LIFE-LINE(TM) VASCULAR ACCESS SYSTEM
K Number: K895030
·
Decision Apr 17, 1990
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
6
Review Days
252
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Basic Information
- Device Name
- LIFE-LINE(TM) VASCULAR ACCESS SYSTEM
- K Number
- K895030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Applicant
- Medical Engineering and Development Institute
- Date Received
- August 8, 1989
- Decision Date
- April 17, 1990
- Product Code
- LJT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Medical Engineering and Development Institute
| K Number | Device Name | ||
|---|---|---|---|
| K902477 | WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET | Aug 24, 1990 | Substantially Equivalent |
| K902469 | BYRD DILATOR SHEATH SET - TEFLON | Aug 23, 1990 | Substantially Equivalent |
| K902502 | BYRD STAINLESS STEEL DILATOR | Aug 7, 1990 | Substantially Equivalent |
| K893480 | BYRD EXTRACTOR SET | Jun 23, 1989 | Substantially Equivalent |
| K890820 | LOCKING WIRE GUIDE STYLET | Mar 22, 1989 | Substantially Equivalent |