Multi-Med Multi-Lumen Central Venous Catheter
FDA 510(k) K955839 · Baxter Edwards
510(k) numberK955839
Submission
- Device name
- Multi-Med Multi-Lumen Central Venous Catheter
- Applicant
- Baxter Edwards
Irvine, CA, US - Received
- December 26, 1995
- Decision date
- March 25, 1996
- 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 |
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|---|---|---|
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| K981909 | Baxter Hemostasis Valve IntroducersDYB · Traditional | 11/24/1998SE |
| K980487 | Carpenter-Edwards Classic Ring with Duraflo Treatment Models 4425 (Mitral) and 4525…KRH · Traditional | 07/07/1998SE |
| K965137 | Fogarty Valvulotome Model 700091MGZ · Traditional | 06/04/1997SE |
| K964021 | Intramed Side Branch Occlusion (Sbo) System (700095 and 700099)HCG · Traditional | 03/27/1997SE |
| K952638 | 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to AS the…LYK · Traditional | 07/28/1995SE |
| K944214 | Baxter Handle Model 1150DTJ · Traditional | 02/10/1995SE |
| K944858 | Baxter Eptfe Externally Supported Vascular GraftsDSY · Traditional | 01/05/1995ST |
| K940795 | Swan-Ganz CC0/SVO2 Thermodilution CatheterDYG · Traditional | 05/24/1994SE |
| K926433 | 4.5F Imagecath(R) Coronary Angioscope, COV45LYK · Traditional | 03/23/1993SE |
Questions and answers
When was Multi-Med Multi-Lumen Central Venous Catheter cleared by the FDA?
Multi-Med Multi-Lumen Central Venous Catheter (K955839) received a 510(k) decision of Substantially Equivalent on March 25, 1996, 90 days after the submission was received.
What is the product code of K955839?
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.