Vascular Access Port Kit
The Vascular Access Port Kit is a general hospital convenience kit containing the supplies and accessories needed to access and use an implanted vascular access port, including special non-coring needles, extension sets, and flush syringes, facilitating repeated IV medication delivery or blood draws without repeated venipuncture. Product code PXK is established as a convenience kit under FDA's 1997 Convenience Kits Interim Regulatory Guidance and is under enforcement discretion, not requiring a 510(k) if all guidance criteria are met. Under regulation 21 CFR 880.5965, it is a Class II device subject to general and special controls. It falls under the General Hospital medical specialty and is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PXK
- Device Class
- FDA class 2
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.