FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOUBLE LUMEN SUBCLAVIAN CATHETER
K Number: K823135
·
Decision Mar 7, 1983
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
64
Applicant Total
883
Review Days
130
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Basic Information
- Device Name
- DOUBLE LUMEN SUBCLAVIAN CATHETER
- K Number
- K823135
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- October 28, 1982
- Decision Date
- March 7, 1983
- Product Code
- LFJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LFJ | Catheter, Subclavian | FDA class 2 | Gastroenterology, Urology |
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