Menlo Care, Inc.
Menlo Park, CA, US
Menlo Care, Inc. appears in FDA device records in Menlo Park, CA. FDA records list 31 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 31
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 31 510(k) clearances for Menlo Care, Inc. between 1986 and 1997. The busiest year on record is 1991, with 5. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 1988 | 4 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 5 |
| 1992 | 5 |
| 1993 | 3 |
| 1994 | 3 |
| 1995 | 5 |
| 1996 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964447 | PICC CATHETER/MIDLINE CATHETER | LJS | Substantially Equivalent | |
| K951620 | MIDMARK MIDLINE CATHETER | FOZ | Substantially Equivalent | |
| K945521 | CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY | FOZ | Substantially Equivalent | |
| K950737 | LANDMARK MIDLINE CATHETER | FOZ | Substantially Equivalent | |
| K944968 | LANDMARK MIDLINE CATHETER | FOZ | Substantially Equivalent | |
| K943893 | PERCUTANEOUS GRAINAGE CATHETER | LJE | Substantially Equivalent | |
| K943143 | BILIARY STENT | FGE | Substantially Equivalent | |
| K930048 | SAFE-PICC CATHETER | FOZ | Substantially Equivalent | |
| K933941 | MENLO CARE URINARY DIVERSION STENT | FAD | Substantially Equivalent | |
| K940127 | CENTERMARK SECURING WINGS | KMK | Substantially Equivalent | |
| K923394 | MENLO CARE AQUASTENT SET | FAD | Substantially Equivalent | |
| K931218 | INTROPEEL V | DYB | Substantially Equivalent | |
| K930801 | INTROPEEL | DYB | Substantially Equivalent | |
| K920828 | SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT | FOZ | Unknown | |
| K920133 | VERSACATH SELECTALUMEN INNER CATHETER | FOZ | Substantially Equivalent | |
| K920128 | VERSACATH MAINLINE CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | |
| K920028 | LANDMARK MIDLINE CATHETER | FOZ | Substantially Equivalent | |
| K912358 | LANDMARK ADD-A-LUMEN CATHETER KIT | FOZ | Unknown | |
| K912165 | LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM | FOZ | Unknown | |
| K910566 | VERSACATH(TM) MULTILUMEN SYSTEM | FOZ | Unknown | |
| K910565 | VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY | FOZ | Unknown | |
| K910564 | VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY | FOZ | Substantially Equivalent | |
| K910799 | LANDMARK VENOUS ACCESS DEVICE | FOZ | Substantially Equivalent | |
| K901374 | CENTREMARK(TM) CENTRAL VENOUS CATHETER TRAY | Unknown | ||
| K896774 | STREAMLINE VASCULAR ACCESS DEVICE | FOZ | Substantially Equivalent | |
| K883980 | LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES) | FOZ | Substantially Equivalent | |
| K883866 | NEOSOFT UMBILICAL VESSEL CATHETER | FOZ | Substantially Equivalent | |
| K884259 | MODIFIED LANDMARK VENOUS ACCESS DEVICE | FOZ | Substantially Equivalent | |
| K882242 | LANDMARK(TM) VENOUS ACCESS DEVICE | FOZ | Substantially Equivalent | |
| K862130 | COMFORT-SET* I.V. CATHETER PLACEMENT UNIT. | FOZ | Substantially Equivalent | |
| K860474 | STREAM LINE* I.V. CATHETER PLACEMENT UNIT | FOZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- LJECatheter, Nephrostomy
- KMKDevice, Intravascular Catheter Securement
- DYBIntroducer, Catheter
- FADStent, Ureteral
- FGEStents, Drains And Dilators For The Biliary Ducts
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain