FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM
K Number: K901722
·
Decision Jul 3, 1990
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
6
Review Days
78
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Basic Information
- Device Name
- CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM
- K Number
- K901722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Device Labs, Inc.
- Date Received
- April 16, 1990
- Decision Date
- July 3, 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 Device Labs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930632 | CHEMOSITE IMPLANTABLE DRUG DELIVERY | Dec 22, 1993 | Substantially Equivalent |
| K904417 | CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM | Dec 5, 1990 | Substantially Equivalent |
| K902135 | PERCUTANEOUS INTRODUCER KIT | Aug 1, 1990 | Unknown |
| K883764 | INTRAVASCULAR ADMINISTRATION SET | Dec 19, 1988 | Substantially Equivalent |
| K882064 | LO-CORE NEEDLE | Jul 8, 1988 | Substantially Equivalent |