Centermark(R) Picc Insertion Tray Landmark(R) Midline Catheter Prep Tray
FDA 510(k) K945521 · Menlo Care, Inc.
510(k) numberK945521
Submission
- Device name
- Centermark(R) Picc Insertion Tray Landmark(R) Midline Catheter Prep Tray
- Applicant
- Menlo Care, Inc.
Menlo Park, CA, US - Received
- November 10, 1994
- Decision date
- April 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional | MedSource Labs, LLC | 07/09/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | Poly Medicure Limited | 11/05/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
More from Becton Dickinson Infusion Therapy Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964447 | Picc Catheter/Midline CatheterLJS · Traditional | 04/16/1997SE |
| K951620 | Midmark Midline CatheterFOZ · Traditional | 04/04/1996SE |
| K950737 | Landmark Midline CatheterFOZ · Traditional | 03/29/1995SE |
| K944968 | Landmark Midline CatheterFOZ · Traditional | 03/29/1995SE |
| K943893 | Percutaneous Grainage CatheterLJE · Traditional | 03/07/1995SE |
| K943143 | Biliary StentFGE · Traditional | 02/28/1995SE |
| K930048 | Safe-Picc CatheterFOZ · Traditional | 05/12/1994SE |
| K933941 | Menlo Care Urinary Diversion StentFAD · Traditional | 03/31/1994SE |
| K940127 | Centermark Securing WingsKMK · Traditional | 02/09/1994SE |
| K923394 | Menlo Care Aquastent SetFAD · Traditional | 11/16/1993SE |
Questions and answers
When was Centermark(R) Picc Insertion Tray Landmark(R) Midline Catheter Prep Tray cleared by the FDA?
Centermark(R) Picc Insertion Tray Landmark(R) Midline Catheter Prep Tray (K945521) received a 510(k) decision of Substantially Equivalent on April 6, 1995, 147 days after the submission was received.
What is the product code of K945521?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.