Vygon Latex Free Bionector
FDA 510(k) K052881 · Vygon Corp.
510(k) numberK052881
Submission
- Device name
- Vygon Latex Free Bionector
- Applicant
- Vygon Corp.
Norristown, PA, US - Received
- October 12, 2005
- Decision date
- March 2, 2006
- 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 |
|---|---|---|
| K241587 | pilot TLSLJS · Traditional | 02/26/2025SE |
| K151237 | Nutrisafe 2- ENFit AdaptorPIO · Traditional | 02/09/2016SE |
| K141026 | LeaderflexFOZ · Traditional | 07/30/2014SE |
| K121105 | Nutrisafe 2 Feeding TubeFPD · Traditional | 12/18/2012SE |
| K100163 | Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXFPD · Traditional | 10/13/2011SE |
| K073493 | Hepatostat SetGAM · Traditional | 05/06/2008SE |
| K070705 | Modification to: Latex-Free Bionector, Model# 896.019, 896.039FOZ · Traditional | 11/30/2007SE |
| K061796 | Hepatostat Set, Model 760XGAM · Traditional | 11/02/2006SE |
| K061250 | Multicath ExpertFOZ · Traditional | 09/29/2006SE |
| K062425 | Lifecath S Picc and Midline CatheterLJS · Special | 09/15/2006SE |
Questions and answers
When was Vygon Latex Free Bionector cleared by the FDA?
Vygon Latex Free Bionector (K052881) received a 510(k) decision of Substantially Equivalent on March 2, 2006, 141 days after the submission was received.
What is the product code of K052881?
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.