Port Introducer Kit
The Port Introducer Kit is a convenience kit containing components used to introduce an implantable vascular access port into the patient, including needles, introducers, and related accessories needed for port placement surgery. Classified as FDA Class 2 under regulation 21 CFR 880.5965 within the General Hospital medical specialty, it is under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) when all criteria are satisfied. The product code is OKE. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OKE
- 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 www.Fda.Gov/cdrh/ode/convkit.Html. 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 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.