FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE LYMPHANGIOGRAM SET
K Number: K781575
·
Decision Dec 4, 1978
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
10
Review Days
81
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Basic Information
- Device Name
- DISPOSABLE LYMPHANGIOGRAM SET
- K Number
- K781575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Instranetics, Inc.
- Date Received
- September 14, 1978
- Decision Date
- December 4, 1978
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Instranetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823430 | INSTRA-SAFE | Jan 7, 1983 | Substantially Equivalent |
| K811824 | CAUTERY CADDY PAD | Jul 20, 1981 | Substantially Equivalent |
| K811823 | SHARPS CADDY FB | Jul 20, 1981 | Substantially Equivalent |
| K811822 | TIP-VU | Jul 20, 1981 | Substantially Equivalent |
| K810294 | LINE CADDY | Feb 26, 1981 | Substantially Equivalent |
| K810208 | BLADE SAFE | Feb 12, 1981 | Substantially Equivalent |
| K802865 | SAFE T COUNT | Dec 18, 1980 | Substantially Equivalent |
| K802866 | SHARPS CADDY MAGNETIC & SHARPS CADDY FOA | Nov 17, 1980 | Substantially Equivalent |
| K770894 | NEURO-SORB PATTIES | Jun 20, 1977 | Substantially Equivalent |