FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LANDMARK MIDLINE CATHETER
K Number: K944968
·
Decision Mar 29, 1995
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
31
Review Days
169
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Basic Information
- Device Name
- LANDMARK MIDLINE CATHETER
- K Number
- K944968
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Menlo Care, Inc.
- Date Received
- October 11, 1994
- Decision Date
- March 29, 1995
- Product Code
- FOZ
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by Menlo Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964447 | PICC CATHETER/MIDLINE CATHETER | Apr 16, 1997 | Substantially Equivalent |
| K951620 | MIDMARK MIDLINE CATHETER | Apr 4, 1996 | Substantially Equivalent |
| K945521 | CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY | Apr 6, 1995 | Substantially Equivalent |
| K950737 | LANDMARK MIDLINE CATHETER | Mar 29, 1995 | Substantially Equivalent |
| K943893 | PERCUTANEOUS GRAINAGE CATHETER | Mar 7, 1995 | Substantially Equivalent |
| K943143 | BILIARY STENT | Feb 28, 1995 | Substantially Equivalent |
| K930048 | SAFE-PICC CATHETER | May 12, 1994 | Substantially Equivalent |
| K933941 | MENLO CARE URINARY DIVERSION STENT | Mar 31, 1994 | Substantially Equivalent |
| K940127 | CENTERMARK SECURING WINGS | Feb 9, 1994 | Substantially Equivalent |
| K923394 | MENLO CARE AQUASTENT SET | Nov 16, 1993 | Substantially Equivalent |