FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM
K Number: K830438
·
Decision Mar 17, 1983
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
64
Applicant Total
40
Review Days
36
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Basic Information
- Device Name
- MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM
- K Number
- K830438
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medcomp
- Date Received
- February 9, 1983
- Decision Date
- March 17, 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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| K092347 | PRO-PICC CT | Sep 16, 2009 | Substantially Equivalent |
| K091953 | PRO-PICC | Sep 16, 2009 | Substantially Equivalent |
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| K091586 | VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN | Jul 23, 2009 | Substantially Equivalent |
| K091466 | 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 | Jun 17, 2009 | Substantially Equivalent |
| K081775 | THE MEDCOMP .010 VASCULAR GUIDEWIRES | Mar 25, 2009 | Substantially Equivalent |